infocusaug22

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.