Resources

By Joe Gough, MA, Sr. Solutions Specialist, Greenphire Although rewarding, conducting clinical research can create a tremendous administrative burden for site staff. Now more than ever, these pain points are being felt much more acutely.  Challenges, including rising costs, were outlined by the SCRS earlier this year in its Open Letter to Sponsor and CRO colleagues regarding workforce retention and inflationary pressures affecting clinical research sites.  Measuring Site Perspectives to Streamline Operations  This summer, Greenphire conducted a market research survey from sites to examine areas of operational inefficiency, understand site perspectives, and to validate solution enhancement opportunities. The survey questions probed participant recruitment; patient engagement; participant diversity, taxable participant payment implications, budget creation, negotiation, and invoicing expediency, and Sponsor/CRO relationships with sites. These functions represent areas of opportunity for vendors as well as Sponsors, CROs and other partners to improve processes and challenges sites are facing right now.  More than 500 sites responded to the survey. This article highlights a subset of key findings and trends that impact the clinical trial workforce and operational challenges in a “post-pandemic world and economy”. The survey was initiated by email and was global, with 75% of respondents from the United States and the others from Europe and other regions. The sites represented viewpoints from academia, professional research sites, hospitals, and nonprofits. The majority of responders were study coordinators.   Core Issues: Study Volume Level and Site Staff Retention   Greenphire sought to understand the “state of the state” from our site user base.  The SCRS Task Force letter recognized the “Great Resignation,” driven in part by the strain placed on healthcare employees due to COVID-19. We discovered that 63% of sites noted that hiring and retaining employees has been a challenge this year.  Additionally, when asked if their study volume was “back to pre-pandemic levels,” 68% of sites said “Yes”. As such, many sites are indeed being asked to “do more with less”.  For those sites whose study volume was not back to pre-pandemic levels, 25% attributed this decrease to a lack of employees.  These data confirm that “time” is perhaps the most valuable resource right now for operations. It’s critical that trial management solutions provided to site staff are easy to use and fit for purpose to alleviate unnecessary administrative work.  Staff Time for Participant Engagement: More Important Than Ever  Simply put, without patients, there wouldn’t be clinical trials.   Yet with more narrow inclusion criteria and the increase in “personalized medicine” recruitment is often more challenging today. Having maximum time available for recruitment is critical. Therefore, reducing the workload for site staff by improving processes is a continuous goal.  In our survey, 84% of respondents indicated they believe technology can be helpful and positively impact efficiency and support recruitment and retention.  Survey results noted that as a form of “optimizing participant engagement”, providing adequate compensation (expense reimbursement and study milestone payments) was the leading method noted by 75% of sites. Additionally, with respect to having available time, 49% of sites indicated that “arranging for transportation and managing the logistics of patients coming for study visits takes away from patient care and other clinical research tasks.” Recruitment and patient engagement are paramount, yet 43% of sites in the survey indicated lower-than-average enrollment this past year. Open-ended survey responses most frequently indicated lower enrollment was attributed to the lingering effects of COVID-19. One responder commented, “participants are still hesitant to venture out because of COVID-19 or go to a health care facility (especially elderly or immunocompromised).” Other common responses impacting enrollment included: gas prices and economic challenges in general; increasingly stringent study inclusion criteria; and participant compensation and expense reimbursement inadequate relative to the increasing cost of living.   However, study protocols and trial operations have adapted significantly recently, especially out of necessity due to COVID-19.  For example, hybrid technology has slowly been added to complement in-person patient visits for many sites.   37% of sites reported that their protocols require more activities conducted at participants’ homes. In the remote trial context, sites reported that activities such as reimbursing patients remotely aren’t that much of a challenge, but conducting certain study visits and obtaining testing and lab specimens remains difficult for many sites to administer.  Financial Operations and Opportunities: Budget Creation, Negotiation, and Invoicing One of the most revealing and important feedback areas of the Greenphire Summer Survey focused on site financial processes and procedures associated with budget creation, negotiation, and invoicing.     Beginning with study start-up, only 25% of site respondents indicated their budget negotiation process was “very efficient” (as the time to CTA execution is a critical performance measure for sites.)   Most common challenges noted in the survey, again, related back to “time”.  Sponsor and CRO “timely responsiveness” to sites along with “more frequent and better communication” were cited most often as the “key area” for needed improvement.  Offering more “user-friendly” budget templates was also mentioned frequently.  A uniform response across seemingly all sites (also noted by the SCRS Task Force Letter) was for Sponsors to recognize the “increased administrative trial costs for sites due to inflation”. This is a challenging financial reality in the current economy for many sites to remain sustainable.     For survey questions related to invoicing payments, sites highlighted the need for technology that streamlines their financial workflows. 85% of sites prefer “to work with a Sponsor or CRO who invests in technology that alleviates challenges with invoice creation, distribution, reconciliation.”  This is a seven-percentage point increase from a survey conducted jointly by Greenphire and the SCRS in 2019. In addition to invoicing format improvements, expediency is critical! 82% of sites agreed that delays in site payments have a negative impact on site operations.  So, what can be done today? We asked sites what was  “the most important activity” a Sponsor/CRO could do to foster enhanced relationships with sites in 2022, and the number one answer was to “streamline site payments and invoicing” processes. Fully paying start-up costs up front was also a leading area mentioned along with paying invoices promptly (e.g., within 30 days if possible). A Call to Action: Sponsor and CRO Support for Sites  As a provider of financial and logistical solutions, Greenphire is frequently conducting focus groups and issues surveys to understand client preferences for technology and to explore ways we can partner to improve the sustainability of sites and all stakeholders in clinical research.  Science and medical innovation are at an all-time high, and conducting clinical research has never been as important (as evidenced by the COVID-19 pandemic).  However, macroeconomic pressures such as inflationary costs, as well as site staff turnover and patient hesitancy to participate in clinical research are areas we must address together.  We encourage the industry (especially Sponsors and CROs) to understand and invest in the “site experience” and to work together to ensure clinical research staff have access to reliable tools and processes to optimize performance in the management of the important work we all do collectively. About the Author Joe Gough, MA, is a Sr. Solutions Specialist for Greenphire supporting ClinCard for Universities, Hospitals and Research Sites in the US and globally. Mr. Gough previously worked in the Department of Medicine at the Medical University of South Carolina and the VA Cooperative Studies Program, Department of Veterans Affairs Headquarters and is an SCRS Member. Greenphire is a financial technology company supporting global financial lifecycle management for clinical trials.

In January 2022, the SCRS team was faced with yet another pandemic dilemma. To avoid hosting an event in a surge of Omicron COVID-19 cases, we decided to move the Global Oncology Summit to May. We considered how we could expand the Summit in those four months, and the answer was clear. The SCRS Diversity Awareness Program has been growing substantially, so it was only natural that a Summit focused on diversity in clinical trials would be the most impactful. From that idea, the Diversity Site Solutions Summit became reality.  Jerome Adams, MD, MPH, former U.S. Surgeon General and Executive Director of Health Equity Initiatives at Purdue University, started the Diversity Summit by highlighting the success of Operation Warp Speed, which accelerated the development and distribution of COVID-19 vaccines and diagnostics in record time as one of the most diverse clinical trials to date.   Dr. Adams also shared a quote from Martin Luther King Jr. “Of all of the forms of inequity, injustice in health care is the most shocking and inhumane.” King said those words more than 50 years ago, and there is still much to do. That’s why SCRS wanted to host this event. Speakers representing sites, patient advocacy groups, Sponsors, CROs and solution providers discussed patient perspectives on diversity, how Sponsors and CROs can support site diversity goals, lessons and challenges with diverse patient engagement, site diversity training and much more.  A major takeaway from the Diversity Summit suggested that initiatives to engage underrepresented populations need to be sincere – not merely a reaction, checklist or industry fad. This involves ensuring sites and studies have appropriate budgets to support community outreach, participant transportation, and multi-language support or translation services, for example. Many sites expressed that Sponsors they have worked with don’t offer outreach funds to better engage with these underrepresented communities, which is something that needs to be addressed if we are to move the needle in the right direction. Inclusion should be a driving principle in clinical trial design, not just a quota. As Seneca Harrison, Chief Diversity Officer at hyperCORE International and CEO of Quality Clinical Research said, “Sponsors advocate that they want diversity, but there is no action. Don’t talk about it, be about it.”  Additionally, awareness of how to engage diverse populations is still a challenge. Simply putting research sites in a local community is not the secret to improving enrollment. We need to work with locally engaged, passionate and diverse community members and site staff to help attract more diverse participants and build trust. Explore multiple avenues for community outreach. Have an open house, lunch and learn, or host community events. Work with local physicians to increase awareness and improve accessibility to clinical trials.  Patient advocate Sheila Johnson commented, “Go into communities and talk about clinical trials. Show up with love and concern. Know your patients. Be culturally sensitive. Don’t invite patients to the table after the table is already formed.” Site diversity training should be at the top of every Sponsor’s to-do list. That training should discuss the meaning of diversity, what it means to enroll diverse patients, and how targets can be set. Sites not only need to recruit diverse populations but also need to know how to retain them. Train sites on how to actually engage and build relationships with underrepresented communities. Changing the dialogue surrounding diversity in trials starts with education, access and trust. The SCRS Diversity Site Assessment Tool, also known as the DSAT, encourages sites to analyze their knowledge and capability of meeting diverse enrollment goals. Several Sponsors are already encouraging the DSAT to be completed as a prerequisite for sites before study opportunities are provided.  Sandy Amaro, Head of Clinical Trial Diversity at Pfizer commented, “It was such an honor to attend the first Diversity Summit. To be surrounded with so many passionate people gave me more energy and drive to move this work forward at a faster pace. I look forward to what we can achieve together over the next 12 months. We need to go into the second Diversity Summit talking about actions taken and impacts made!”  Nearly 400 sites, Sponsors, CROs, solution providers, patient advocacy groups and students joined us at the inaugural Diversity Summit. Thank you to Total Diversity Clinical Trial Management and Parexel for generously providing registration scholarships for research sites, patient advocacy groups and students to attend. It’s clear from the conversations at the Summit that there is still much work to do, but we are headed in the right direction. Coming together to collaborate, share ideas and best practices, and discuss solutions for how to move forward together made an impact. SCRS encourages everyone that joined us to share what you learned with your organization and network. We look forward to growing the impact of the Diversity Site Solutions Summit as we extend the conference to one-and-a-half days. Join us next year in Austin, Texas March 30-31, 2023!  SCRS Oncology Community Reunited  This year, we finally reunited with our oncology community again in person after holding the event virtually in 2021. Scheduled immediately after the Diversity Summit, the Oncology Summit saw record registration with nearly 400 attendees. Voices from sites, Sponsors, CROs, solution providers and patients discussed topics such as site budgets, technology, workforce challenges, and diversity specific to oncology clinical research.   A favorite session for Summit attendees is always the Site Landscape Survey, and SCRS collected oncology-specific data to represent challenges and insights facing cancer research today. One of the biggest obstacles the SCRS Site Landscape Survey explored is site staffing. Survey results showed that 63% of oncology research sites have encountered significant challenges maintaining their current workforce over the last 18 months. The role with biggest reductions and hiring challenges is unsurprisingly site coordinators, due to a lack of experienced individuals in the job pool, sites’ lack of financial ability to compensate employees at current salary rates, and employees leaving for other opportunities. What can Sponsors and CROs do to help alleviate this challenge? Sites indicated providing adequate budgets to support the hiring of needed staff is the most critical need. Additionally, providing an active flow of trial opportunities, support for training new research personnel and support for hiring and applicant marketing would help sites address workforce challenges. Decentralized trials continue to be a focus of discussion for the industry, yet 63% of oncology sites surveyed said they were not approached to conduct a decentralized oncology trial. 43% of oncology sites that were approached for a decentralized trial declined to participate. Why? 50% of the oncology sites said they are in a “wait-and-see” approach for decentralized trials. By contrast, 66% of sites in other therapeutic areas were approached to conduct a decentralized trial. Clearly there is a need for oncology-specific technologies, opportunities, and education.  Increasing diversity in oncology trials was also a hot topic of the Summit. Deena Bernstein, VP of Customer Success at Datacubed Health, led a session on strategies to increase minority enrollment in oncology trials. “We discussed how cancer trials have a high level of complexity. Adding another challenge to them is the enrollment of diverse and minority populations,” said Bernstein. “With diverse representation in oncology trials, we know that we will have access to more accurate, robust outcomes to represent more cancer patients. Our panel and audience talked and shared insights about how education, community-based healthcare providers on the front line, addressing health literacy, and including patient optionality are the things we all need to focus on to achieve the goal of reaching more diverse people to participate in oncology trials.”  Underserved populations can benefit from increased access to novel drugs in clinical trials, rather than waiting for drugs to become FDA-approved treatments, yet they aren’t participating. Bernstein added that the session attendees discussed how proper education about the trial can help move the needle. Also, many patients are unaware that placebos aren’t used in cancer trials and treatment would never be held back. Involving the patient’s family throughout the trial is important to ensure everyone understands and trusts the process. Involvement from primary care providers (PCPs) and communication between PCPs and oncologists are important for building trust and continuity of care. Lastly, introducing a clinical trial in a comfortable setting by a Nurse Navigator (a liaison between the patient and clinical care staff) can help navigate the patient through the clinical trial and treatment process and help patients make informed decisions.  Kim Kundert, SVP of Site Development Services at Total Diversity Clinical Trial Management also participated in a diversity and inclusion-focused session, commenting that the enthusiasm of the audience – which included all industry stakeholders – was memorable. “As a presenter, you always worry about lack of audience participation or questions when you ask them. That was not the case in this session. There was a sense of collaboration which isn’t always commonplace in the clinical trial industry.” A recurring theme throughout every SCRS event is that Sponsors are encouraging sites to ask for what they want and need. “Everyone knows that in order to move the needle on diversity in oncology trials and clinical trials in general, it will take all of us working together,” said Kundert.  Another Summit attendee added, “I absolutely loved the stakeholder comradery bringing deep insights on how to operate oncology trials. It was refreshing to see more consideration around the patient perspective in study design, reimbursements for sites and participants, and inclusivity to remove burdens for all.”  At the end of the Summit, Peter Fredette, Oncology Strategic Site Solutions Director at IQVIA, was announced as the new SCRS Oncology Board Chair. After the Summit, Peter shared goals for his new role with SCRS as well as his favorite moments from the event on the SCRS Talks podcast. Registration for the 2023 Global Oncology Summit from March 31-April 1, 2023 in Austin, Texas is open now.   Highlights from Australia-New Zealand  It’s hard to believe it had been more than two years since the Australia-New Zealand community came together in person. Once again, SCRS was proud to see registration for this Summit grow to record levels. We always do our best to ensure an equal representation of sites and industry at our events, and the ANZ Summit was evenly split 50/50!  SCRS VP of Site Engagement, Jimmy Bechtel, kicked off the Summit with SCRS Honorary President David Vulcano and Tam Nguyen, Associate Professor and Deputy Director of Research at St. Vincent’s Hospital Melbourne with the Australia-New Zealand Site Landscape Survey insights. Other plenary sessions included the importance of site collaboration, looking at how the clinical research profession has changed and the trial compensation process in Australia.  All sessions received high marks, but the “Exploration of Clinical Research as a Profession” plenary that shared a patient’s perspective made a notable impact. Discussing challenges the patient went through after an adverse reaction to the treatment in the trial, it was a call to action for the industry to reform the trial adverse event reimbursement process. Cheryl Ann Hawkins, Chief Operating Officer at Emeritus Research added, “This session had massive engagement and interest, and I have learned that patients need to have access to much improved legal support in Australia if they were to suffer serious side effects from a clinical trial. Looking forward to part two next year!” Attendees also enjoyed breakout sessions as unique opportunities to network while discussing the CT:IQ InFORMED Project, study start-up, site audits and managing expectations with Sponsors and CROs. Vanessa Irvine from Gallipoli Medical Research Foundation reflected on the Summit, saying “This was my first SCRS conference experience, and I will be going back for sure! It was great to meet others in the industry, and really feel like it was a collaboration. I went back to my site and couldn’t stop talking to my staff about all I had heard.” Dates for the 2023 Australia-New Zealand Site Solutions Summit will be announced soon. With the growth of the Summit, we are exploring new venues which may be the new home for the July 2023 Summit in Melbourne, Australia. If you are an SCRS member or Global Impact Partner, contact info@myscrs.org for a special registration code for all SCRS Summits. 

By Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare Clinical trial vendors often get overly excited about the potential of technology to reduce site workloads. After spending nearly 20 years at community clinical trial sites and academic medical centers, I know that technology doesn’t always lead to less work for sites–especially when technology means dozens of separate systems.   But it’s also true that sites need to spend less time on paperwork and data entry. With the rapid growth of clinical trials in 2021 and 2022, many major sites have a backlog of anywhere from 30-70 studies that they simply don’t have time to start.  At SCRS Oncology Summit 2022, I took part in a discussion about how sites can close their capacity gap to successfully complete clinical trials. We came to the conclusion that technology can reduce the burden on overworked sites–but only if that technology is well-integrated and connects sites to Sponsors. Sites need help with their workloads  A record 1,015 new trials started in Q4 2021. At the same time, many sites faced employee shortages and turnover rates of 50%.   With staff leaving in such large numbers, sites can’t hire fast enough to keep up with trial workloads. In an industry where turnover was already problematic pre-pandemic, the increased instability of today’s job market is placing added pressure on study timelines across the board.  We already know that out of all the treatments that fail in Phase III clinical trials, roughly 22% of them fail solely because the trials last so long that Sponsors run out of funding. One can only imagine what these statistics will look like in five years if sites and Sponsors cannot figure out ways to make running trials easier.   At first glance, it seems like technology would be an obvious answer to some of the industry’s problems. If sites and Sponsors can leverage technology to help offset manual workloads and decrease administrative burdens on both sides, we can potentially focus on getting new treatments to market faster.  But too often, technology actually ends up adding work rather than streamlining it. The rush to solve problems with new software and devices has left many sites stuck managing too many systems that aren’t well-integrated.   Why the wrong technology doesn’t reduce work for sites  When sites are forced to use disparate systems, technology can slow down processes instead of accelerating them. 42% of sites log into 6 or more platforms for an average study. These platforms can range from CTMS systems to electronic Investigator Site Files, eConsent systems, EDC platforms, and Sponsor portals.  The lack of integration between these platforms means that site staff have to waste time on duplicative data entry. As a result:   61% of sites say they wish they could manage all of their operations in a central platform  40% of sites say they hesitate to adopt new technology because of a lack of integrations  Some technology vendors try to solve this problem by creating a “closed system.” This means that the platforms integrate–but only if you buy all of them from the same vendor.  Sites often struggle with closed systems because of their lack of flexibility. If you already have software, you won’t be able to integrate it with a new closed-system platform. Because of this challenge, I believe technologies that have an open API and can integrate with one another will serve sites better.   The importance of an open API and integrations  Software with an open API has the potential to integrate with software from other vendors. For example, a site could integrate its eISF or eTMF from one vendor with a CTMS, EDC, or EMR from another. Open-API software lets sites choose the best-in-class platform for each of their needs, then integrate those platforms to eliminate repetitive data entry. But how can sites find open-API software that integrates well?   The first step is to ask tech vendors whether their software has an open API and what integration services they offer. If a software platform doesn’t integrate with any of your pre-existing software or software you may want in the future, it’s probably not a good fit. It’s also important to look for technology that lets you collaborate remotely with Sponsors and other sites.  How well-integrated technology can help sites collaborate with Sponsors 91% of Sponsors already use remote monitoring or expect to do so by the end of 2022. That means that sites with remote access technology will have an easier time meeting Sponsors’ expectations and keeping up with the rapid pace of trials.  However, remote monitoring doesn’t automatically mean less work for sites. If sites have to do all of their work in a different software system and then upload documents into Sponsor portals, they end up spending more time on a monitoring visit than they would if the monitor just came on site.  This means the workload is no longer worth the reward for sites, and they will be less likely to adopt Sponsor technology and more prone to charge additional administrative fees to cover the time wasted on duplicate entry. This is why it’s important that sites and Sponsors choose technology that is reflective of site workflows and that allows data sharing through open API. Sites deserve technology that helps them manage data and documents throughout the study lifecycle while still allowing them to facilitate remote monitoring and data sharing with sponsors.   As an example, an eISF with remote access empowers Sponsors or CROs to continually check on site documents throughout the trial, instead of waiting for check-ins every few months. This leads to more accurate clinical trial documentation.  When using an eISF for remote monitoring:  75% of Clinical Research Associates could identify issues with site documents sooner  68% of CRAs could help sites fix those issues more quickly  Meanwhile, sites benefit from a platform that already matches their workflows and that integrates with their pre-existing clinical trial platforms.   Bringing in new, frontier sites to keep trials running  But if we want research sites to keep up with the changing pace of clinical trials, we can’t just make sites more efficient–we also need to engage more sites in trials.  There are a limited number of academic medical centers (AMCs) in the U.S., and they serve a limited patient population, as only 30% of patients live within 2 hours of an AMC. If smaller community sites, like pharmacies and local physicians’ offices, get involved in clinical trials, it will greatly expand the pool of patients who have access to studies.   Pfizer and Moderna successfully used community sites to find a large and diverse pool of patients for their COVID-19 vaccine trials. The Pfizer trials alone enrolled more than 46,000 participants, 42% of whom were Asian, Black, Hispanic/Latinx, or Indigenous/Native American. Although these trials weren’t as diverse as the world’s population, they were considerably more diverse than average vaccine clinical trials, which are roughly 78% white.   Adding community or frontier sites also makes trials more patient-centric:  Patient advocacy groups rank transportation to trial visits and out-of-pocket travel expenses as major barriers for clinical trial participation  60% of rare disease patients liked that decentralized trials helped them spend less time traveling  But new clinical research sites aren’t always prepared for the burden of running clinical trials. This is where experienced research sites and technology can step in to help.   How experienced research sites can use technology to help new sites  New, community-based clinical trial sites can make trials more inclusive and patient-centric. But these frontier sites aren’t always prepared for the amount of regulatory documentation involved in clinical trials.   This is where technology can help. Remote access software lets experienced sites partner with less experienced sites to centrally manage some of the more administrative workflows, like regulatory and data entry.  In turn, community-based sites can help AMCs and major hospitals by taking care of patients closer to home.   Integrated technology can help sites run efficient, inclusive trials  With the number of new clinical trials growing each year, it’s impossible for existing research sites to keep up with demand without embracing technology. But technology will only help sites work more efficiently if it integrates with their existing platforms, matches their workflows, and connects them with Sponsors and each other.  Fortunately, sites are becoming more empowered to tell software vendors and Sponsors what they need. Sites can now request eISFs that offer site-friendly workflows and let them collaborate remotely with Sponsors and community sites: and with that technology, they can overcome their capacity shortage and keep trials moving forward.  This topic was also discussed on the SCRS Talks podcast. Listen now below: About the Author  Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. Now Florence Healthcare’s Chief Clinical Trial Officer, she has worked in multiple therapeutic areas in both academic and community hospitals and most recently served as the Director of Clinical Research Administration for the Vanderbilt-Ingram Cancer Center. Catherine has an MBA in Healthcare Administration from Belmont University and a Masters in Modern European History from Loyola University Chicago. She is a Certified Clinical Research Professional (CCRP) and a Certified Clinical Research Coordinator (CCRC) as well as a subject matter expert and key opinion leader on patient-centric, decentralized and hybrid trial design. She is passionate about changing the clinical trials industry and empowering women as leaders.

By Aspen Insights As most clinical research sites well know, patient recruitment remains one of the largest challenges in clinical research in 2022. A recent paper in National Institute for Health suggests that more than 85% of research studies fail to meet recruitment goals and up to 50% of sites are unable to recruit more than one patient for a given trial. Is it the increasingly restrictive trial criteria that is eliminating candidates, or is it simply too much for a recruitment coordinator to qualify vast populations of patients manually? Regardless of the why, enrollment is staggering – affecting sites, sponsors, and patients alike.   How can sites actively work to remove themselves from this statistic?  Use a data-driven approach to project enrollment during feasibility analyses to make sure you are only taking on studies that fit your specific patient population. Replace manual candidate identification through chart review with artificial intelligence [AI] technology that prequalifies patients by comparing structured and unstructured patient clinical data to robust inclusion & exclusion [I/E] trial criteria. Streamline your recruitment workflow through EMR integrations that connect you to patient clinical data and CTMS integrations that seamlessly convert candidates to participants. Aspen Insights recently completed a case study on the use of Aspen Forge, its AI patient-trial matching platform, to compare its enrollment effectiveness to that of traditional recruitment methods. This case study summary compares enrollment outcomes across three different recruitment methods for a pediatric infectious disease trial conducted by a site that is partnered with pediatric practices throughout the site’s surrounding community. Artificial Intelligence Candidate Identification Aspen Insights was contracted by a site to perform candidate identification for a pediatric infectious disease study. By performing a simple search integrated with the site’s EMR system, 45,000 potential candidates were identified through AI Candidate Identification technology. Of those, 1,894 candidates fit the study criteria by applying numerous temporal aspects to the search query. An estimated 862 hours of chart review time was saved by using unique machine learning and text interpretation software for this pediatric study alone. Traditional Patient Referrals from Partner Practices Due to the site’s relationships with pediatric practices, 76 patients were referred directly from the practices for study participation at the point of care. AI Candidate Identification randomized nearly 180% more patients when compared to Traditional Patient Referrals from Practice Partners. External Patient Recruitment Campaigns Using traditional patient recruitment campaigns, the site brought in 133 interested candidates, who still required validation as qualified candidates. However, using advanced artificial intelligence, the number of interested leads generated was double compared to the traditional recruitment method. Overall, 56% of the site’s total number of interested candidates originated through candidate identification through EMR-integrated machine learning technology. This recruitment method accounted for 64% of the site’s randomized subjects, representing over 1.8 times the number generated through traditional recruitment methods combined. The effectiveness of utilizing this type of technology is further illustrated through the site’s pediatric study outcomes: Provided the site 200 prequalified candidates ready for screening on Day 1 of the study opening to recruitment. The site’s average monthly enrollment was 3X more over all other participating sites. The site exceeded the enrollment goals set by the sponsor by 150%. The site saved upwards of $25,000 in one month on study nurse salaries with the use of AI patient identification instead of manually reviewing 45,000 patient records. 12 competing sites randomized less than 5 patients. 15 competing sites failed to randomize a single patient. It is evident that the solution to today’s recruitment challenges is the adoption of advanced technologies for the purpose of more easily identifying quality candidates to pursue for research. Although this market is still being shaped and influenced, it’s clear that sites that continue to rely only on traditional methods for recruitment may be leaving potential trial participants behind.

With an interest in making study participation more convenient, more sponsors are implementing a Bring-Your-Own-Device (BYOD) study model in which participants use their own personal devices to submit assessments. Not only does this approach eliminate the burdens associated with unfamiliar provisioned devices, but it also means participants don’t need to worry about charging and carrying a second device. Patient-reported outcomes (PRO) are increasingly included in drug development programs to capture participants’ perspectives on a variety of domains as well as to support labeling claims. This trend coincides with increasingly decentralized study designs and accelerated technology adoption. Collecting patient-reported outcomes data via BYOD is thought to improve more than just convenience for trial participants – it may also drive compliance as participants are more likely to see study-related reminders on their own smartphone or tablet device. As a result, electronic PRO (ePRO) data capture methods are now standard, having proven to offer benefits to all stakeholders. For example, sponsors can collect more and better-quality data from more participants while improving adherence to study requirements, and participants experience fewer burdens and increased convenience. In addition, ePRO offers flexibility in terms of how data are captured but prompts questions about device selection and modalities. To investigate sites’ perspectives on one such modality, Signant Health’s Therapeutic Advisor, Katie Garner, conducted a qualitative study to further investigate the attitudes and experiences of site personnel involved in two global studies using BYOD to collect patient-reported outcomes, with an aim of understanding and alleviating potential pain points. STUDY GOALS • Compare attitudes towards BYOD and provisioned device usage• Identify advantages and challenges associated with each approach• Understand how site workflows for patient onboarding change depending on the selected technology• Evaluate training materials• Obtain overall feedback and improvement suggestions KEY FINDINGS SETUP EXPERIENCE Participants who chose BYOD needed to download the app at their site visit, after they had completed the consent process. For provisioned devices, sites needed to scan and record the device details for inventory tracking. Both approaches took roughly the same amount of time to complete. One reported issue encountered during BYOD setup was that participants didn’t remember their app store password. This could be mitigated by ensuring that reminders to access app store credentials were provided ahead of the clinic visit. All site staff interviewed felt there was not a significant difference in time or complexity between the two approaches. However, they generally preferred the BYOD set up process because it required participants to be responsible for and more involved in device set up, reducing burdens for site staff. In fact, site staff could continue with other aspects of the visit administration while the participant was performing this activity. TRAINING All site staff commented that training would be useful to help them explain to participants the benefits of the BYOD approach and encourage its use. The site staff cited the benefits listed: 1. Participants do not need to carry an additional device 2. There’s a greater familiarity with personal smartphones and tablets 3. Using the participant’s own network provider is thought to lead to optimal connectivity for data submission (although global roaming SIM cards for provisioned devices can use multiple networks to ensure good connectivity) 4. An increase in data collection compliance can be expected Some site staff perceived that participants upgrading or changing devices during the study might forget to reinstall the study eCOA app. TECHNICAL Most sites transitioned a number of participants from provisioned devices to BYOD mid-study due to phone upgrades or participants changing their preferences. One site staff member reported that a small number of BYOD participants did not receive completion reminders, and only after investigation did they discover that they had silenced reminders in their device settings. Other participants complained of multiple reminders even though this helped them complete their data entry. Some participants requested to not receive push notifications until the site staff explained their importance. COMPLIANCE One staff member reported they had to keep reminding participants using provisioned devices who had turned off their phones or did not charge them to continue to make ePRO entries. One way to address this would be with a BYOD approach, since patients typically have their own personal phones charged and with them at all times. RECOMMENDATIONS WHEN USING BYOD PATIENT & SITE TRAINING • Communicate the benefits of BYOD to sites and in participant materials to clarify the benefits and facilitate conversations and informed decision-making. • Remind participants to remember app store credentials ahead of their study visit. • Ensure a process is in place to enable participants to reactivate the ePRO app in the event of changing or upgrading their device. • Enable effortless transition from provisioned to BYOD based on a change in participant access to suitable smartphone technology or participant preference. • Provide screenshots of the app and participant handbooks for site reference Download this whitepaper to learn more about the goals, methods, and results of this original research.

As the industry faces unprecedented macroeconomic issues, including substantial staffing challenges and inflationary pressures, resources are desperately needed to support clinical research sites and studies. To help address these challenges, SCRS established a Task Force, which provides best practices and collaborative solutions for both sites and industry to navigate some of the most critical issues in clinical research right now. The Task Force committee is comprised of some of SCRS’ largest site network members and has already distributed several deliverables, including a site toolkit and an open letter to industry partners. Committee co-chairs David Vulcano, SCRS Honorary President and VP of Clinical Research Compliance & Integrity at HCA Healthcare, William Smith, CEO of Alliance Multispecialty Research and Task Force member Jeff Kingsley, CEO of Centricity Research, talked through what the committee is doing to mitigate these workforce and inflationary challenges and how industry partners can help. The catalyst The idea for the Task Force came at the beginning of the year when William Smith was looking at trends and turnover among his site staff, as well as the inflation and projections around their cost structure for the year. In discussions with other sites, it was clear that many of them were facing the same challenges and were unsure how to move forward to ensure their sustainability. “We felt that one-on-one discussions with Sponsors and CROs would not be as productive as a group discussion hosted by SCRS,” commented Smith. SCRS has heard from several sites that are concerned about the issue of staff turnover and the inflationary pressures affecting their business. That’s exactly why the Task Force was created – to collectively represent the site voice, outline challenges sites are facing, and encourage Sponsor and CRO partners to start a dialogue with sites to address these issues. Tools for sites A site toolkit has been developed to aid sites in managing costs, negotiating, and retaining staff, for starters. Many of SCRS’ largest site network members contributed ideas and best practices to share in the toolkit. “We have an ethical obligation to solve what we can on our own,” said Vulcano. One particularly helpful area of the toolkit targets minimizing staff onboarding costs and helping with ideas to bring site staff onboard while minimizing delays. There is also advice to help ensure new staff are adequately trained and that they’re able to execute studies with minimal errors. Managing site cash flow and staffing challenges As site costs increase with inflation, cash flow is becoming a significant issue. The site toolkit discusses how to manage costs, negotiate for monthly payments, and plan for cash flow disruptions. The goal is to provide sites with best practices and strategies to make sure they can survive the current economic environment as successfully as possible. Understanding the current rate of inflation and its impact on budgets for multi-year studies is especially important right now. What sites charge for certain line items this year should not be the same as what they charge in the following years. “Inflation increased substantially, which means our cash flow is going to be negatively impacted today and into the future. We’re bound by contracts that we have today that were negotiated before. Contracts that we negotiate tomorrow will be more aggressive because we know the inflationary environment that we’re in today. But sites are going to suffer in between,” added Kingsley. Site staff turnover With the current rates of staff turnover, site staff that had long-standing relationships with trial subjects may no longer be there. Turnover doesn’t just impact sites – more importantly, it impacts the subjects and their willingness to begin or continue trials. Clinical trial participants are also being affected by macroeconomic pressures, such as heightened transportation costs. Smith commented, “It’s much more than the financial health of the sites. It’s our ability to enroll. It also affects our ability to retain these subjects and to make clinical trials a positive experience.” With the lack of talent options available in all sectors of clinical research, it has become more common for CROs to recruit coordinators from their studies. Normally this may not be an issue if adequate or extended notice is provided, but some CROs have provided recruits incentives to start immediately. This practice often leaves sites scrambling to find, onboard, and train new staff quickly. SCRS suggests that if industry partners need to recruit site staff to work for their organizations, there should be some sort of study continuity plan negotiated with the site. “The industry is desperate for people. CROs need more CRAs, for example, and so they recruit a site coordinator, but it’s not in the best interest of our industry. Sites are having to replace those people. It’s concerning when an experienced clinical research coordinator leaves a site to become a CRA because the quality of the data at the site level is greatly impacted by having novice staff,” said Kingsley. Employee turnover impact on site success Everyone in the clinical research industry can create errors. But meaningful errors that contribute to trial failure and success, such as participant qualifications and protocol deviations, all happen at the site. Fundamentally, reducing errors at the site should be everyone’s focus. Kingsley commented with novice coordinators, enrollment may not be as strong as with an experienced coordinator, and error rates may be higher. Kingsley shared, “It takes, in my opinion, at least a year for a coordinator to get their feet underneath them. The same is true of investigators and other roles at sites. It takes a great deal of experience to begin to understand what you’re doing, why you’re doing it, the nuances, the fine details.” Smith added, “In addition to the loss of efficiency that we see with staff turnover and training new people, it also requires a lot more time from the PI to do effective oversight because new employees are more at risk for mistakes. You must be much more involved. You must spend more time answering questions, educating them.” Monitors from the Sponsors and CROs have also experienced similar turnover, which means many of the monitors are less experienced as well. It can take significantly more investigator time when interacting with monitors and vendors. Research has shown that certified coordinators and principal investigators produce better enrollment, fewer errors and get fewer 483s. Will the inverse be true with the current level of site staff turnover? David Vulcano shared a story from a recent meeting with industry Sponsors. “I’ve had the honor of representing SCRS at a few meetings over the past couple of months. One was a closed-door meeting with some senior executives at Sponsor organizations to discuss how this issue affects sites. I generated a meme of Big Bird sitting at a table with some executives looking stunned and out of place. The caption was ‘When the receptionist shows up to work to find out they’re now a CRC.’ All the Sponsors were laughing. Then I said, ‘I know this is funny, but the sad part is that Big Bird is probably a CRC on your study.’ The room got silent, and I had their attention.” When a site loses a coordinator, one of the first impacts is the site may no longer have the capacity to conduct upcoming safety visits. The site may look at removing the subjects from the study. Second, the trial subjects may withdraw on their own if they were close to their study coordinator. Many times, subjects love the coordinators they have been working with, and when they lose that personal connection it’s one less motivating factor to continue this study. Additionally, sites may need to halt enrollment in studies because they may not have the capacity. What can sites do to retain top talent? Some ideas outlined in the toolkit were to conduct salary surveys, revisit benefits, establish culture committees, and practice employee career mapping, for starters. The toolkit also shares how to onboard employees quickly to set site teams up for success. A call to action for Sponsors and CROs When initially creating the open letter, SCRS planned to share with its Global Impact Partners. However, we quickly realized the call to action applied to all industry partners. The open letter suggests Sponsors and CROs should be open to respectful and honest dialogue about these economic pressures and staffing concerns. Consider ways to help sites right now: can existing budgets be adjusted? If not, what other solutions may be available? Traditionally, sites might receive pushback from industry partners that may say current rates are not fair market value. However, rates from one year ago, or even a few months ago, are not applicable today. Sites are paying higher fees for staff and supplies already. When negotiating, sites should share supporting documentation whenever possible and provide examples showing increased costs. SCRS also encourages sharing or referencing the open letter drafted by the Task Force as additional support. Smith added that his site is working towards renegotiations right now, saying “We are currently in the process of refining some of our increased costs. We plan to send the SCRS open letter with a cover letter to discuss issues that are more specific to our sites and ask for help.” It’s important to acknowledge this isn’t happening in one area of the country or world, and it’s not isolated to certain types of sites. It’s happening to sites of all types and sizes. The industry is in this together, but we need to ensure conversations are happening and action is underway. Continuing the conversation Sponsors and CROs have expressed to SCRS that they want to hear from sites. Because when sites are suffering, studies suffer, and that impacts all the work we do as an industry. How can sites ensure their voices are heard? Kingsley suggested, “Don’t be afraid to bring up this conversation with Sponsors and CROs. You’ll be surprised how often they will help you if you have an open, honest conversation about what you’re seeing. Emphasize in these discussions that the current situation is not sustainable. Industry must view sites as a partner and help come up with solutions that will keep sites economically viable and keep their workforces stable. This will enable sites to participate in their clinical trials and for those trials to be successful.” “Be active. Make a change today aimed at reducing turnover, bringing new people in and getting them up to speed as rapidly as possible. Discuss solutions with your site’s leadership teams,” Smith added. The Task Force is planning opportunities for continued dialogue between industry and sites. We also encourage SCRS members to contribute to discussions online and at SCRS events. If sites or industry partners have ideas about recruiting or retaining employees, or strategies that have helped mitigate some of the inflationary pressures, please share. Learn more about the open letter to industry Sponsors and the site toolkit available to SCRS member sites on the SCRS Task Force page.   Listen to the SCRS Talks episode

On July 1, 2022, the Centers for Medicare & Medicaid Services (CMS) published the overdue form required for providers and sites to bill Medicaid for routine care in qualifying trials. This form is a new requirement under a recently passed federal law (Section 210 of the Consolidated Appropriations Act of 2021) that requires all states’ Medicaid programs to cover such services. It has been hypothesized that the added requirement of this form will have the opposite impact of the law’s intent of increasing trial enrollment of Medicaid beneficiaries and will subsequently negatively impact the diversity, equity and inclusion of trial populations. SCRS is continuing to educate Congress on this issue and is keenly interested in sites’ experience with its implementation, specifically if it has impacted trial enrollment positively or negatively. While changing the law’s requirement of the form will quite literally take an act of Congress, SCRS has been successful in working with CMS to develop a more streamlined form than the original draft issued 6 months ago. Overall, the discussions with CMS resulted in having the scope clarified so that the federal level is only to create the form and, because Medicaid is a state-implemented program, each state will have to answer questions on the implementation of the form and what we are supposed to do with it. Frequently Asked Questions Do we have to use this form? If a site and/or an affiliated healthcare provider are expecting to have routine care in a qualifying trial reimbursed by Medicaid instead of the research sponsor, then yes, the form is required for each patient by the new law. What if a subject has Medicaid as secondary insurance? Will the form still be required (i.e. if Medicaid is only picking up copays and deductibles)? According to CMS, if Medicaid is being billed then the form will be required regardless of the amount. How is “routine care” defined? The law defined “routine care” essentially as: (i) any item or service provided to prevent, diagnose, monitor, or treat complications resulting from such participation, to the extent that the provision of such an item or service to the individual outside the course of such participation would otherwise be covered under the State plan or waiver; and (ii) any item or service required solely for the provision of the investigational item or service that is the subject of such trial, including the administration of such investigational item or service; and (B) does not include— (i) an item or service that is the investigational item or service that is— (I) the subject of the qualifying clinical trial; and (II) not otherwise covered outside of the clinical trial under the State plan or waiver; or (ii) an item or service that is— (I) provided to the individual solely to satisfy data collection and analysis needs for the qualifying clinical trial and is not used in the direct clinical management of the individual; and ‘‘(II) not otherwise covered under the State plan or waiver. What is a “qualifying clinical trial”? The law defines a “qualifying clinical trial” as: The study or investigation is approved, conducted, or supported (which may include funding through in-kind contributions) by one or more of the following: (I) The National Institutes of Health. (II) The Centers for Disease Control and Prevention. (III) The Agency for Healthcare Research and Quality. (IV) The Centers for Medicare & Medicaid Services. ‘‘(V) A cooperative group or center of any of the entities described in subclauses (I) through (IV) or the Department of Defense or the Department of Veterans Affairs. (VI) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. (VII) Any of the following if the conditions described in subparagraph (B) are met: (aa) The Department of Veterans Affairs. (bb) The Department of Defense. (cc) The Department of Energy. (ii) The clinical trial is conducted pursuant to an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or an exemption for a biological product undergoing investigation under section 351(a)(3) of the Public Health Service Act. (iii) The clinical trial is a drug trial that is exempt from being required to have an exemption described in clause (ii). What if I am a site that is not a Medicaid provider – does this give me the eligibility to start billing Medicaid? It’s possible, however you will have to check with the beneficiary’s state Medicaid program, especially if you are in-state. We are an outpatient site doing a study that requires routine care billed by a third party provider (e.g. a hospital, surgery center or other physician’s office). The Sponsor states they want the providers to bill Medicaid for the routine care of the qualifying trial. Who is responsible for getting the form? Technically the billing entity is responsible. However, pragmatically speaking, the nature of the form indicates that the site/PI would obtain the form. Does the new law cover out-of-state or out-of-network providers? Generally, yes as the law states coverage shall be made without limitation on the geographic location or network affiliation of the health care provider treating such individual or the principal investigator of the qualifying clinical trial. Of note, the billing provider still has to follow the beneficiary’s state Medicaid process for obtaining reimbursement. Such provider is strongly encouraged to understand the beneficiary’s state nuances and reimbursement rates prior to conducting services. Does the new law have any expediency requirements? The new law requires states’ coverage decisions shall be expedited and completed within 72 hours. Is there anything else other than the form that is needed? The state may require other items. The law currently states that they shall not require submission of the protocols of the qualifying clinical trial, or any other documentation that may be proprietary or determined by the Secretary to be burdensome to provide. Will this add to site costs? Yes, it will likely add to site costs ­as it is extra work, compliance risk and tracking. Sites that are intending to bill Medicaid for routine care should be in contact with their Sponsors and CROs about the added burden on site costs as well as diversity/equity/inclusion plans. CMS has indicated that the following will be decided by each individual state: Whether a form can be signed in counterparts (i.e. one signature signed locally and another supplied by fax or email scan which collectively is two signatures). If the form must be signed PRIOR to enrollment in the trial and obtaining routine care services or if it can be signed after services are rendered Can the healthcare provider be a physician or can other disciplines sign in that capacity? What are we supposed to do with the form? Is it to only be housed in the patient’s record or is it to be submitted with the bill? The law requires the form effective January 1, 2022. However, the form was not published until July 1. Are sites/providers required to obtain a form to attest for services provided January 1, 2022 through June 30, 2022? Or is this only effective July 1? Will the form be required for items and services billed on or after July 1, regardless of when the patient was enrolled? For example, if a beneficiary was enrolled in a qualifying clinical trial in 2020 and will receive routine care services in August of 2022, will a form be required? What revisions to the proposed form was SCRS successful in obtaining in the final version? We obtained that the Principal Investigator can also sign as the Health Care Provider which was a huge win, as it eliminated the need for the patient to see another physician. We eliminated having both the written name of the trial and “link to the trial” as the trial identifiers and only have a single trial identifier, that of the NCT number from www.clinicaltrials.gov We were able to educate CMS that the title is not “Principle Investigator” but “Principal Investigator”. We were able to remove the requirement of adding the PI’s and Health Care Provider’s NPI number on the form under their signature. The original form asked for the patient’s name 3 times and their Medicaid ID number twice. We were able to get those consolidated into only asking for that information once. The form was originally two pages – the first page being narrative and the second page gathering the information, which is not ideal for 2-sided scanning. We were able to reduce it to a single page. We at SCRS will continue to educate Congress on the impact of this form on Medicaid beneficiaries’ ability to enroll in clinical trials. We need your help in giving us your experience and data. Please reach out to communications@myscrs.org to share your experience.

Clinical tech has been evolving at a rapid pace to solve study-facing challenges. At the 2019 Global Site Solutions Summit, SCRS hosted a Global Impact Partner meeting where we asked, “what is the one priority that our industry needed to heighten awareness and prepare for as we approach 2020?”  We left that meeting with an understanding of decentralized clinical trials (DCTs).   “I can’t imagine if we hadn’t prepared for some of that work,” commented Sean Soth, VP of Global Business Partnerships for SCRS. “We worked hard on virtual capabilities, educating the market on what DCTs were. But that’s just one small example of technology that still has many questions.”  While the industry has seen exciting advancements in DCTs and even more technology is being added to the alphabet soup of innovation, sites find themselves in the age-old problem of being asked to do more with less or not enough.  It’s not just investment that matters – it’s the ongoing barriers to training, implementation and user experience that continually impact research site operations and outcomes. Technology innovation often gives way to burden without the insight of practical approaches and understanding of how sites will apply these solutions. The ideas shared in this Sites NOW discussion will explore how we can narrow this gap.   The most important needs in clinical tech right now  Panelist Gary Schwartz said that finding end-to-end solutions that are more platform-based or provide a one-stop shop for sites is a strong trend. This eliminates linkages and interfaces between data modules and applications, as well as the number of site logins required to access various systems. Being able to simplify not only the vendor relationship and management, but the interactions with those technologies, is a critically important need. This will help sites simplify their interactions with a particular trial, as well as the patients participating.  Industry is also looking at how they impact the patient because in the end, that is most important. How do we simplify those interactions? Patient centricity is mentioned frequently across the industry, but awareness is growing that patient-centricity can’t happen without site-centricity. If sites can’t attract patients, then all stakeholders in the industry suffer.  How can site centricity and patient centricity coexist?   With the currently growing shortage of staff, sites want to leverage technology to help them optimize their internal operations so they can focus more on patients. The goal is for technology to help site staff spend more time on higher-value tasks.   However, because all the technology systems may not communicate well or may not perform as well as expected, sites end up spending significantly more time than anticipated using different platforms. “Sites end up actually taking a step back when they were hoping to take a step forward,” said panelist Henry Kravchenko. “That’s a painful thing to see because you should be adopting technology that helps you move forward. If it’s not doing that, it’s a structural issue that needs to be dealt with on multiple levels.” Panelist Shivani Shah shared a site perspective. What are some of the higher-value tasks that sites are hoping systems will help them solve?  Shah agreed sites need platforms that are end-to-end and simpler for both sites and patients. In the same vein, one of the bigger problems sites are trying to solve is remote and hybrid visits and how technology can support that. Sites need technology that’s easy for them and their patients to use while providing more visibility and oversight for investigators.   Vendors that have a suite of options, versus individual vendors that capture certain data, are becoming more attractive to industry partners as well.  “Our challenge right now is that we have a few different softwares that we’re working on in terms of our functional requirements. The next step is how to make sure to have all of this on a consistent platform,” said Shah.  To elaborate on remote and hybrid visit needs, Shah shared that sites are looking for more technology infrastructure around the shipment of labs, making it easier and more convenient for the patient and providing sites with more visibility in ensuring the protocol is followed.  E-consent is also one of the recurring hot topics of discussion for industry. “From the site and patient standpoint, we’re still experiencing growing pains where we have multiple options to work with, but it’s not airtight. We see the benefits of it, but oftentimes we have seen that it increases visit duration, especially for elderly patients,” said Shah.  When and how do sites introduce new solutions to their team and locations? Shah commented that when introducing options for the team, they have a dedicated department that is constantly looking for innovative ideas and strategies. “It usually goes to a pilot phase of introducing it, trying it out with a small team and a smaller site, and then getting all the stakeholders involved with their feedback.” Committees would also be a great option for sites or industry partners that want to share technology ideas and experiences.   Reflecting on how far the industry has come, panelist Mark Ryan shared, “I’ve been doing this a long time – over 25+ years – and was a coordinator before I came to Bayer. I remember some of our biggest concerns back then were where the sealed randomized codes in the envelope were going to be stored at a site. Where do we put that? How did we get signatures on delegation logs on a piece of paper? We had to fax them around to different people to get signatures. Those were big technology challenges back then.”   Today, there are shiny new objects for clinical trials coming out every week. People want to do things differently and try to make life easier, but it’s getting more complicated and even more challenging. “It’s not just challenging for sites – it’s challenging for Sponsors and patients as well,” commented Ryan. Introducing new tech to sites  Ryan also discussed what his organization, Bayer, is doing when preparing to share new technology with their site partners, adding, “We’re trying to keep up with what we need to do to be better. Because at the end of the day, we’re trying to get medications to patients that need them faster. Along the way, we created some challenges for ourselves that were hard to overcome.”  There is still a lot of trial and error that happens along the way when bringing new technologies to sites and ensuring they work as needed. One of the big takeaways Bayer has heard through site feedback is many sites don’t know about the technology needed for their trial until they get closer to getting that site open. “Often, we don’t know which technology we’re going to be using, or which vendors we’re going to be using when we’re doing feasibility. We’re trying to get that moved up earlier in the process so sites can make an educated decision based on the technology needed for their study,” expanded Ryan. What technology should sites own as opposed to being needed by Sponsors? Shah shared that sites should have more say and ownership in areas of studies that are patient-centric, especially with e-consent and e-diary technology. “It’s less of an imposition if we can work together.” New roles to support technology needs  Training and site support are high on industry’s list of priorities. If there’s an issue, how do we stop the finger-pointing between technologies? CROs should consider having specific roles to help sites with technology-related questions. Ryan added that the CRA may not always be the best person to deal with technology inquiries, so Bayer has created specialist roles that manage technology on a more repeated basis. Schwartz echoed that industry is looking for people that can manage solutions across the enterprise and recommend technology platforms for trials. It takes special skill to understand all the available options when selecting which decentralized clinical trial technologies are right for a particular protocol. Specialists are currently needed to handle the study startup functionality – writing the specs, working with the vendors to make sure they’re developed correctly, and that they’re operated properly going forward. If CROs put people in place to help solve those problems, then over time that expertise will be disseminated amongst the organization and there will be less need for that specialized function.   The volume of tech  60% of sites polled in the May Sites NOW meeting said they are using 20+ systems on a daily basis. However, that number increases even more when considering other systems that are needed less frequently.   What happens when a site is already using certain technologies and the Sponsor asks the site to use a different vendor for the same technology? Sites expressed that they have turned down studies due to not agreeing with protocol technology or vendor requirements, and that trend may continue to increase as more technology options emerge. Sponsors should remain flexible and communicate early with sites to manage this. Schwartz added, “There are so many players involved in the decisions, and what’s best for each organization comes down to a desire to have a common understanding of how we move forward in a cohesive, efficient manner. For example, if you’re trying to attract a site that has a very rare population, there may be more flexibility. In the old days, it seemed to be a ‘my way or the highway’ approach to attracting sites and I believe that has changed dramatically. How do we work together to solve some of these problems so that we can all move forward? We try to create those avenues of interaction with our site partners so that we can get that feedback and understand how to make our organization easier to do business with.”  One of the challenges in the clinical research industry is there are many vendors trying to address the needs of all stakeholders simultaneously, and it often doesn’t work. There are different types and sizes of sites with different needs, so the same solution might not be applicable. It’s especially important for technology providers to adapt their solutions based on the customer and end user. The core infrastructure should be the same, but have the ability to serve multiple stakeholders in a way that fits their business model.  Designing the ideal study  If you could design your next study from scratch, what would you do to change your approach to technology?  In the breakouts, we discussed this very idea. One idea shared was open APIs so technology providers could share data securely with one another and reduce redundant data capturing that is required for different systems.   Have sites involved early in the protocol development to decide what technologies might be the best fit. Even solution providers should consider getting input from sites as well. SCRS Site Advocacy Groups are a great avenue for garnering site feedback. Invite sites to test beta versions of the platforms, make tech support available 24/7, and available in multiple languages.   Eliminating redundancy in training is also a substantial need. The industry would benefit from competency training that can be applied to multiple vendors and technology platforms.  Duplication of training programs could be eliminated via common globally standardized, and industry-accepted systems where information and documentation of competencies can be commonly shared in order to eliminate redundancies and burdens at the site level. Do you have feedback to share on this topic? Consider joining us at an upcoming Site Solutions Summit or Sites NOW discussion.   Watch the full Sites NOW meeting recording here. 

By Jennifer Sheller, Head of Monitoring Excellence, Trial Diversity & Site Engagement, Global Clinical Trial Operations, Merck Recent site surveys and feedback from industry conference attendees show that sites are looking for a collaborative relationship with sponsors to drive more productive conversations and foster better-informed decision-making. In fact, an SCRS site study dashboard white paper reported that 76 percent of sites never receive feedback from sponsors on their study performance, except for recruitment metrics. Survey respondents noted that they needed actionable performance information early in the process in order to take quality to the next level. What features should sites be looking for? What would help sites gauge their performance? Here are some considerations that both sites and sponsors can deliver: Organized and visual presentation: Compelling data will always be more impactful if it is clear and engaging. Relevant key performance indicators (KPIs) depicted in a convenient report will provide sites and CRAs with a vantage point for charting progress and focusing on areas to improve. This can include enrollment, start-up timelines, data entry, query resolution and protocol deviations. Real-time tracking: Sponsors and sites that can share insights throughout a clinical trial develop strong partnerships. For example, a report that shows patient screening and randomization metrics allows a site to monitor enrollment progress, highlighting how many patients were targeted before the activity began, the current number of patients in a particular study and how this compares to other sites in a given study. Transparent benchmarking: It is an advantage for sites to know how their own performance compares to other sites within a given study at the country, regional and global level. Equipped with this information, sponsors can discuss specific strengths and collaborate with sites on areas for improvement to take action. Insights to elevate discussions: CRAs can generate reports to proactively prepare for site visits, help sites interpret their data and anticipate site needs throughout the study. By continuing to update reporting based on end-user feedback, sponsors can make site conversations as effective and efficient as possible. Sponsors should offer a unique perspective and support to boost clinical research sites’ operational excellence. A site’s clinical trial performance data, when shown visually and in the context of other study measures, can enhance sponsor-site collaboration. This is critical to the identification of issues and collaboration to secure quality and compliance and manage expectations. Merck is committed to providing access to this robust information. Site personnel who would like to learn more can ask their Merck CRA about Site Health Check, a reporting tool designed by sites for sites to help focus on what matters—ultimately resulting in better quality research and operational excellence.

By Will Wing, Director, Innovation and Feasibility at Clincierge Healthcare and technology have always gone hand-in-hand. In fact, some of medicine’s earliest innovations are the most enduring. Invented in 1816, the stethoscope remains one of modern medicine’s most widely recognized symbols. First used in 1895, X-rays paved the way for electrocardiograms, CT scans, dialysis machines, and more. For clinical trials, the convergence of healthcare and technology creates a constant stream of innovation in the pursuit of novel treatments and therapies. Likewise, the pandemic and subsequent growth of decentralized trials demonstrate how technology can play an essential role in the patient experience. COVID-19’s impact on innovation   At the onset of COVID-19, clinical research organizations (CROs) and trial sponsors embraced quick digital transformations to ensure trials continued and patient care remained uninterrupted. A 2021 survey of clinical operations leaders at CROs, academic medical centers, trial sites, and other industry segments found 47% of study sites and 36% of sponsors increased technology investment to minimize disruptions due to COVID-19. Major investments focused on remote connectivity and access technology. Companies that proactively ramped up their use of technology saw the most significant benefits. Today, the pharmaceutical industry is doubling down on innovation. Many organizations are devoting vast resources to technologies aimed at advancing their mission. Some are adding innovation to the c-suite, and some, like Clincierge, are building teams focused on innovation and feasibility. How technology benefits trials From straightforward software applications managing data collection to complex systems integrating nearly all elements of a trial, technology has the potential to improve almost every aspect of clinical trials. CROs and trial sponsors are already using technology to address long-standing challenges like patient recruitment and retention and data security. Technology also enables the industry to adopt decentralized clinical trials and remote patient care. Cloud-based systems and artificial intelligence are streamlining data collection and greatly reducing time spent on data analysis, resulting in shorter trials and benefitting both sponsors and patients. Similarly, wearable devices and telemedicine offer safe at-home solutions which reduce site visits, resulting in easier methods of recruiting and retaining trial participants. While the focus tends to be on technologies to improve the clinical and research phases of trial design, innovations to ease the burdens of participation for patients and caregivers could be equally beneficial to trial outcomes. Just as sponsors use technology to find and recruit patients, patient service providers can integrate technology to improve patient experiences. Technology developed with patients in mind is critical. Not only is every trial unique, but so is every patient. The most effective approaches to technology are at least flexible, if not customizable. They must account for elements such as location, the severity of patient health, patient comfort with technology, local regulations, and privacy. Successfully addressing patient needs with technology has the added benefit of freeing up trial staff, allowing them to focus more time on data collection and crucial trial endpoints. Patient support services in clinical trials While technology can improve trial efficiency and enable remote operations, it is important to note technology alone cannot replace the human element of patient care. Consider a hypothetical trial with 1,000 enrolled patients, each required to visit the trial site 12 times per year. That equates to 12,000 site visits over the course of just one study. At some point, patients will have questions or special requests that require human interaction. Many CROs and trial sponsors look to patient support services providers to manage a wide array of logistics, such as reimbursements of out-of-pocket expenses, patient transport, housing, and translation services. Patient coordinators become trusted advocates, providing hands-on support to ease emotional and logistical burdens for trial patients and their caregivers.” Patient coordinators become trusted advocates, providing hands-on support to ease emotional and logistical burdens for trial patients and their caregivers. These relationships are especially essential in trials involving rare diseases or pediatric patients, which often require cross-border travel and complex medical accommodations. Tech-enabled innovation streamlines business services and empowers clinical trial teams to focus on serving patients. For all of the benefits that technology provides, it is important to remember they can be quickly overshadowed when reliance on technology feels like more of a hindrance than a source of support. A human touch will always be essential, whether on an individual level or the ability to reach an experienced team when things go wrong. As we continue developing and refining what it means to build patient-centricity into clinical trials, the overarching goal remains: selecting the most effective tools to improve the patient experience and deliver life-saving and life-enhancing products to market.

By Chris Wells, Senior Director, Patient Concierge, at Illingworth Research Group, a Syneos Health™ company More non-essential appointments are moving from virtual back to in-person visits at sites, bringing up new worries for clinical trial participants and resurrecting some old ones. Where site visits are essential, travel and logistics support can make a huge difference to ease the burden imposed on patients and families. Getting patients and their caregivers to sites has been an ongoing challenge, but recent patient concierge technologies are on the market to help ease patient (and site) transportation burden. Travel and logistic support can make a huge difference, especially those traveling longer distances, traditionally marginalized or chronically ill. By working with a patient concierge service to ensure logistics – from ground, air, and rail travel to short- or long-term housing accommodations and out-of-pocket expense reimbursement – are managed according to the visit schedule, pressure can also be relieved from site teams to ensure a smoother patient experience. As site administrators investigate the details of these services in order to identify the most effective transportation program to connect patients and sites, there are four critical questions to ask of any potential vendor: Can you connect with non-fluent English speakers? More patients and their caregivers are expecting fluent outreach (and support) in their native languages. Any service that is meant to help patients connect to their healthcare providers – especially in a clinical trial setting – should be offered in several languages, not just English. Is your service user-friendly? When evaluating the potential effectiveness of a site transportation program for patients, sites need to think through the user experience. Does your service offering include mobile-friendly (and non-mobile!) ways to make appointments and view travel-related reimbursement expenses? Are there hidden fees for sites after start-up? Some services require sites to sign up to all, or a minimum portion of professional fees. Other providers limit the number of communication exchanges between the site and patient/caregiver.  These can expose clients to paying for activity regardless of site or patient uptake, providing no incentive to deliver a quality service since revenue is guaranteed. Does the service integrate well with our specific patient population, and will it add value? A trusted transportation vendor will have experienced patient coordinators with a vested interest in proactive and efficient patient management and should be experienced in building a rapport with patients and families. A robust, patient-centric approach not just provides a better trial experience to participants, it enables sites to confidently recruit from further afield. Clinical trial patients and their families can often be faced with unique and often indication-specific transportation challenges that can be affected by the distance between home and site. At Illingworth Research Group, a Syneos Health™ company, we believe no person should have to forego healthcare – or basic social needs – because they cannot get there. Our mission is to help to ensure that every patient, especially those that are traditionally marginalized or chronically ill, can access the care and resources they need to ensure good health. Having a travel vendor that understands and appreciates these niche requirements is key to removing patient burden, offering both compassion and a duty of care to those who need it.

The phrase “patient-centricity” has been circulating the healthcare and clinical research industry for quite a while. What does patient-centricity really mean and how can we ensure our practices are meeting and exceeding that definition?   The March Sites NOW meeting tackled all things patient-centricity and discussed practices industry can implement now to impact study success.  Improving Study Design from Start to Finish  In a Sites NOW poll, 49% of respondents said they currently have patient-centricity policies and procedures in place, while 30% have procedures in development, and 21% don’t have any patient-centric procedures in the works. Patricia Roselle, Sanofi, stated that before you consider exploring any patient-centric processes, keep in mind the strategy should span all the way from pre-trial to post-launch. It’s an ongoing process that involves conducting surveys throughout the study, asking open-ended questions about patients’ research experiences, and following up every six months with surveys.   Getting feedback at the end of a study is too late – if there are trends across sites, protocol amendments should be considered. We can’t assume things are still working well – we need to get feedback continuously.  Learning throughout the trial and acting as quickly as possible to implement any needed changes will have a massive impact on patient retention.    Health authorities and industry are experiencing a learning curve to understand how science can be fused with patient insights for better integration. Traditionally, sponsors have known the simplest way to implement patient-centered initiatives is to start at the study design phase to reduce burden.  When looking at study design, consider how it impacts Diversity, Equity and Inclusion (DEI) efforts. Some long-standing inclusion and exclusion criteria are inherently biased and severely limit potential participants. Address this by ensuring protocols are easier for patients to qualify for participation in studies. Although protocol amendments can be a pain point, they are incredibly important when they impact who can be included in a study.  The patient experience can also be improved by reducing patient/caregiver inconveniences through means such as providing transportation, reimbursement, and home health care options.  As part of industry’s collective efforts to make clinical research more understandable and approachable to the general public, we need to keep in mind that patients are people. How do they feel about the term “patients”? Industry can create more comfort by asking patients how they want to be referenced.  Creating patient-centric practices is usually a budget issue, so industry partners need to walk the walk and support it in every way on a project basis. If CROs are unable to allocate additional funding for a particular study, keep it top of mind for future studies.  Patient Champions  Patients, sites, CROs, sponsors and vendors all need to be a part of the conversation in order to make patient-centricity a reality. This means all stakeholders need frequent site and patient feedback to better understand patient experiences. It’s not something only one arm of clinical research can tackle, as Sites NOW panelist Ellen Price mentioned. “Without collaborating with sponsors and CROs, we wouldn’t be able to bring these patient-focused plans to fruition.”   Sites, find your like-minded, patient-centric champion who shares your values and can have conversations around patient engagement programs. Ask your CRO partner to connect you with the right person who will be your partner/advocate and communicate patient needs and feedback to enact change. Be persistent! CROs value hearing from sites and may not get to speak to them often, so your input is important.  What is our industry missing with patient centricity and how can we help change?  After the presentation, Sites NOW attendees divided into groups for further discussion to share thoughts on what industry is missing with patient-centricity.   One insight is that not everyone wants to do things the same way, so flexibility and options for patients are important. Additionally, industry tends to group patients in specific therapeutic areas together and generalize their needs without considering individual patient barriers. We need to understand the patient before writing a protocol.  Listen to sites in the early stages of protocol development for input on what may or may not work. Site Advocacy Groups are a great tool for this. Also, industry needs to consider how sites will manage flexibility options operationally.  The conversation was mixed in regards to finding a balance with technology use in trials. We’re adding many new technologies to studies, but are they all patient-centric? Technology can add a lot of stress on study coordinators to manage, where 30% to 40% of their time is spent at the computer dealing with technology. Tech support services are needed to remove this burden from sites. Consider what can we offer through telehealth and other virtual means to assist patients with accessibility, keeping in mind simplicity is the key for both sites and patients. As the industry looks to implement more patient-centric approaches, we also need to consider how to provide meaningful support and services to patients without adding burden to sites.  If you want a glimpse of what participants experience in your trials, “Volunteer to be a research participant yourself to experience the process.”  The full meeting recording featuring Patricia Roselle from Sanofi, Lisa Dyment of PPD and Ellen Price of Meridian Clinical Research is available to view here. 

By Juliet Martin Originally published on Clinical Trials Arena We’ve heard and used the term “patient centricity” for years now, and with good reason. It’s an important consideration in the healthcare industry, including the clinical research space. But there’s a related issue rarely discussed, although it should be: the relationship between patient centricity and site centricity. One could argue patient centricity is not possible without site centricity, as sites deliver the patient experience in clinical trials. The best intentions of any sponsor or contract research organization (CRO) make little difference if sites fail to engage with participants. Here are three strategies and examples of how site centricity ensures trial success and a positive experience for your participants. Listen to site experiences and suggestions for improvement Jessica Perry, Director of Patient Centricity at Moderna, is an industry advocate of the important role sites play in patient centricity. In a recent podcast interview with Advarra’s Aidan Gannon, Perry said, “We have to ensure that when we’re looking at trial designs and looking at operationalizing trials, that we are considering the type of burden that we’re putting on the sites.” Perry went on to note sponsors shouldn’t pass up the opportunity to leverage the experience sites bring to the table and should invite them to share their insights and learnings. “The sites and investigators we work with are incredibly important to us,” she said. “And we want to ensure that we have a true partnership with them.” Address challenges sites face with process improvements and support How else can the industry become “site-centric” and better help sites deliver the patient experiences needed for a successful trial? Taking note of the common challenges site leadership describe is a good starting point. The following were previously shared in focus groups with Advarra’s Longboat Platform team: Customize experiences to accommodate physicians and healthcare partners who work differently Accommodate participants of varied types and backgrounds Integrate clinical research activities and support into investigators’ and site staff’s existing workflows Maximize staff efficiency and effectiveness Provide varying materials and resources for effective staff training Establish an effective workflow across sponsor and site technology, and allow sites to utilize their own technology One can easily imagine how problems in any of these areas could negatively impact the participant experience at the site. An overwhelmed, poorly organized, or inadequately trained site is not well-positioned to deliver on the sponsors’ and CROs’ patient-centric goals. There could be bigger consequences as well, including compromised data and protocol deviations. A top-20 pharmaceutical company conducted a challenging Phase III breast cancer study in 16 countries across North America, Europe, and Asia. Due to its tight timeline and small participant population, this particular study had very little room for miscommunication or error. By providing custom training, engagement options, guided visits, and more via Advarra’s Longboat Platform, they successfully conducted this complex trial. The support provided by the sponsor and CRO within the Longboat Platform reduced screen failures by 50%, protocol deviations by 21%, and supported twice the participants enrolled per site. Investing upfront pays off Fortunately, sponsors and CROs have the power to address these issues and improve the clinical research experience for both sites and participants. Advarra’s technology for sponsors, CROs, and sites: Improves communication and transparency Improves site efficiency Reduces burdens on staff and participants Streamlines the clinical trial experience Inevitably, lower burden on sites results in more time available for patient care and engagement.

By Kelly McKee, VP Patient Recruitment and Registries, Medidata New medicines and vaccines are made possible through the participation of clinical trial volunteers who provide data to sponsors and research teams as part of the drug approval process.  Traditionally, sponsors and CROs have relied on clinical trial sites to ensure that participants have positive clinical trial experiences and have spent little time designing or optimizing experiences from the perspective of a patient. If we are to make meaningful change in access, inclusion, and equity in clinical trials, the patient experience must improve. Historically, patient participation and engagement have been limited to study visits and entirely confined to site and patient interactions.  Technological innovations and the emergence of Decentralized Clinical Trials (DCTs) have brought some of these interactions from outside the study site and into patient’s homes through innovations such as electronic informed consent (e-Consent), electronic patient-reported outcomes (ePRO), diaries (eCOA), live video visits, and sensors. Too often, these technologies are implemented singularly, with little or no regard to the holistic experience needs of the patient.  Engaging Patients Pre-Trial Not all patients are prepared to participate at FSR (First Site Ready).  Clinical trial participants are people and making the informed decision to participate can be a complex and emotional process.  Patients need time to become educated on clinical trials, and to feel engaged and empowered to choose clinical trials as an option. By engaging patients early through pre-trial registries, sponsors and CROs can provide information to help patients make the right choice for the right trial at the right time. Additionally, patients can be asked to provide their preferences on trial experience via surveys and registry data capture to help design more patient-centered trials.  Engaging Patients Post-Trial Clinical trial participation may end with LPLV (Last Patient Last Visit), but expecting that a patient doesn’t need to be engaged beyond their last visit is short-sighted.  With the vast majority of patients (95%1) being willing to participate in another study, providing additional opportunities to patients just makes sense.  Historically, data provided by clinical trial participants has not been shared with these individuals or their healthcare teams when their participation has come to a close.  In the 2017 Transcelerate survey, “What do Clinical Trial Participants Want?” a clear majority of respondents favored patient data return with 81%2 and 83%2 requesting data return during and after a trial, respectively.  It is incumbent upon us to make it easy for sponsors to return data to patients and easy for patients to receive this data.   Why is a Unified Platform Experience Important? As DCTs continue to gain popularity, the industry has been inundated with point solutions for each step of the clinical trial process. This has resulted in a disjointed and chaotic experience for sponsors, sites and patients having to use multiple systems and portals for a single study. A unified solution is needed to bridge the gaps between data and workflows so that patient data is entered only once and automatically drives downstream workflows such as randomization and dosing calculations. Additionally, a single destination patient portal enables patients to engage in all of their clinical trial activities with one login. This unified experience not only gives patients continuous support in and out of a trial, but improves experiences and retention.  At Medidata, we believe that the right combination of tools, people, and processes can create better patient experiences while enabling sponsors and CROs to execute faster, smarter trials driven by high-quality data. References: CISCRP. (2021). Perceptions and Insights Study: Participation Experience. https://www.ciscrp.org/. Retrieved April 1, 2022, from https://www.ciscrp.org/wp-content/uploads/2021/11/2021-PI-Participation-Experience-Report-04NOV2021-FINAL.pdf TransCelerate BioPharma Inc. (2017). What Do Patients Want? https://www.transceleratebiopharmainc.com/. Retrieved April 1, 2022, from https://transceleratebiopharmainc.com/wp-content/uploads/2017/11/What-do-Patients-Want-Visualization.pdf

By Alexandra Charge,Practice Lead, Clinical Solutions, Real Chemistry Eva Kaczykowski, Director, Digital & Social Media, Real Chemistry “Trial Participation is Most Frequently a Result of Physician Referrals.” This is a fact often quoted in industry research, with the expectation that treating physicians and community healthcare providers (HCPs) should be the binding glue in patient engagement and inclusion in trials. Therefore, connecting with them directly to raise awareness about trial options available for their patients, can close the gap in the equation. The evidence suggests there is a keenness to refer, but the challenge of how – how to learn about and access trial information, how to talk about trial options, and how to refer – is a constant barrier. However, a lack of access to clear information should not be an issue in our digital world. Digital Transformation Pre-pandemic, the digitalization of healthcare was well underway, however in the years since, there has been a marked increase in uptake of digital channels and strategies for disseminating information. Healthcare is more digitalized, accessible, and connected than ever before. Reaching a wider network of people, coupled with the eventual uptake of decentralized clinical trials by the industry from pilots to near normalized, may at last provide the right combination in engaging, and enabling, all the stakeholders needed for clinical trial recruitment success. Facts & Figures In 2020, doctors increased their sharing of medical information on Twitter by 26% YOY resulting in greater access to scientific information by consumers. Pre-COVID, only 18% of UK Family Medicine/General Practice specialists said they held online meetings with colleagues, whereas 56% have begun holding online meetings with colleagues since COVID. EU-based oncologists & hematologists are active social users, with 42% going online 8+ times per day for professional purposes.    A record number of around 1,300 trials with a decentralised and/or virtual component will likely initiate in 2022, representing a 28% increase from 2021. A recent McKinsey survey with leaders across the life science industry shows an expectation that overall decentralization levels will reach ~60% across all activities within the next 5 years. The Challenge There remains a marked gap but an ever-growing need for engaging closer with the wider network of HCPs in the paradigm of clinical trial recruitment. This could enable a connection to more patients, better understand patients’ needs in their everyday life and “community” and widen representation and inclusion for trial recruitment through the physicians as “trusted voices” for patients. The ways in which clinical trial awareness resources can be distributed digitally are distinctly different internationally (country by country) to those in the US, due to different rules on patient and HCP engagement at local levels. In addition, direct-to-patient communication on social media and digital channels has recently been further impacted by privacy changes affecting targeting capabilities. In any case, a patient receiving an ad via social media with a link to a trial website without context, cannot transfer the importance or relevance of a trial without an accompanying conversation with their doctor to better understand trial requirements and any concerns. This is even more so the case when considering a highly unmet need in rare diseases, or a time-dependent therapeutic area such as oncology, where the necessity to expedite the time in decision making is critical. Connecting in parallel with both the HCP and the patient and caregiver in raising awareness about a trial as a treatment option, will help have a more cohesive discussion when both are equally aware and versed on the trial options, challenges and expectations and enable a co-educated partnered discussion if a referral is suitable. The trick here to make it viable is removal of burden on the HCP community, to help inspire more HCPs to believe in research, and motivate them to have conversations about clinical trials with their patients. The initial burdens could be multifold, and the list below is only some, among many others: discovering trial options in the first place, understanding the complexity and eligibility which could impact patients, determining what the key discussion points should be with the patient about current treatments vs an investigational drug, and finally, there is a powerful opportunity for innovative but investigational drug access, but this leads to the burden in the risk/benefit determination. Importantly, with an increase in the volume of potential referrals, there is a need for reduction in burden on the PI and clinical trial site staff. But through well-designed, informed, collaborative HCP referrals, the quality of the patient referrals, in parallel to the higher volume of engaged patients, becomes a reality. With a reduction in burden, also must come an understanding of benefit. Sponsors need to take the time to discover what the drivers and barriers may be for HCPs to refer their patients, as each patient population, each investigational drug, each trial design, and each trial landscape & timeframe is different. The solution falls to bringing the right information to the HCPs in the overall treating medical network, enabling them with knowledge through insightful targeted communications, simplifying the evaluation and decision making, and arming them with patient-centric materials and resources. All to help engage easily in a conversation with the patient about all options, while easily connecting with the right resources to compliantly refer to for more detailed questions about the trial. This can only be achieved successfully through our digital and interconnected capabilities. Connecting with physicians on social and digital media channels that they are already active on, and importantly trust, in their personal, educational and professional daily life, is important to purposely and effectively interact with busy individuals. Providing valuable information in an efficient and concise manner is the key to disseminating specialty-specific knowledge about the trial if healthcare providers are to play an essential role in advising, guiding, and supporting patient participation in clinical research. The How Define: In order to best activate a digital HCP referral campaign, we must begin by defining the vision and objectives for the approach. In clinical trial recruitment, we know the ultimate goal is timely patient accrual through successful randomizations, and in this context, from an increase in relevant patient referrals. For a digital campaign this must be translated into achievable and measurable metrics: consider the audience journey and the end goal. This could be pre-screener completions on a trial website, or confirmations via a referral survey to understand how and where successful patient referrals have come from. Discover: Next, it is important to discover relevant insights and data about our key audiences. First, by understanding a patients’ medical, and emotional journeys, to determine the key touchpoints with the various HCPs and their varying influence through their interactions, and then by looking at the physician journeys and behavior to harness a deep understanding of their profiles, including digital behaviors and activity. It is vital to take the time to research on a per specialty and country basis; a one-size-fits-all approach derived from the US landscape cannot be applied globally as each region and each HCP specialty practicing within each country has a unique experience that needs to be understood. Design: The learnings found through audience analysis will then enable the design of a robust campaign via digital channels that HCPs are already learning and connecting on. A multichannel approach (e.g social media, HCP closed networks, paid search) is generally recommended in order to reach the target audience at an increased number of touchpoints, and therefore increase likelihood of message recollection as well as improving the chance of reaching a higher number of HCPs. The onward journey for interested HCPs, to find out more from these digital channels, must be easy; an intuitive and smooth user experience, driving to a trial Knowledge Hub of robust, succinct information via a central website for HCP awareness and learning. Develop: A strong audience, or user journey, can only be effective if driven by the development of clear campaign messaging, materials, and meaningful discussion resources for HCPs to share with their patient community, which are founded in the campaign & business objectives identified at the Define stage. As well as increasing campaign success by effectively engaging physicians, this will widen the inclusion potential as it equips these physicians to become the trusted patient partners in supporting a difficult decision. Deploy & Dissect: Next is the deployment of the campaign, which comes hand in hand with dissecting the campaign, aka analysis, as one of the benefits of digital activation is the real-time learning and optimization of the approach to drive efficiencies and better results. For example, if you are seeing that a certain message or channel is delivering more traffic to your trial website, you can look to redistribute investment to boost the likelihood of referral. Summary A systematic, data-driven process exists to understand the sophisticated nature of the healthcare professionals’ digital communication requirements and potential for successful utilization in clinical trial referrals. This, through the digital and social marketing capabilities combined with the compliance and clinical expertise required to formulate the trial messaging of interest, could be a powerful modern interpretation of the classical “Letter to Colleagues” to drive referrals. The trust-relationship of peer-to-peer interactions has taken a new step forward in online HCP community engagements hence the utilization of these growing social and membership-based channels, needs to be understood and engaged with in the new post-covid digital environment. Through a geographically wide reach enabled by digital and social media, the ability to increase representation of patients can be achieved, and finally democratize access to trials – for patients, and the wide medical community supporting them. A Case Study: Digital HCP Outreach and Referral Campaign for a rare form of cancer The Real Chemistry team worked with a sponsor company on a digital HCP outreach and awareness campaign for increasing referrals for a rare cancer trial. The campaign was successful by generating lots of interest via HCP activity which resulted in more than 660 unique website visits. Due to this success, the caregiver and patient campaign was initiated in parallel, with the knowledge that HCPs along the treatment journey have already seen relevant messaging and will be equipped to answer patient questions about the trial effectively.