Resources

Over 400 clinical research professionals recently gathered at the SCRS Global Oncology Site Solutions Summit in Austin, Texas, for oncology-focused education, networking and a look at the offerings of leading service providers. Sixty-four speakers in 19 sessions over 1-1/2 days provided a wealth of insights and practical tips for clinical research sites, sponsors, CROs and solution providers, such as the following: Technology The current chaos in clinical research technology may pass as providers address their technology problems, superior products become dominant or merge together, fewer new products emerge, and sites discover which technologies best fit their needs. Sponsors should obtain input from sites on the sponsor-provided technologies that sites will have to use. Integration across technologies is essential. Smaller sites often cannot afford modern technology for clinical studies. Patients need options and flexibility in the technology they use (or don’t use). Elderly patients, in addition to any infirmities, may lack general technology competence and affinity. 100% of sites polled in the SCRS Oncology Landscape Survey are open to decentralized oncology studies, meaning some or all components are done virtually or off-site. Site Workforce Workforce is the number-one site issue now. Personnel shortages limit capacity, stress personnel, and can reduce employee retention, productivity and work quality. Because of workforce issues, some sites are refusing studies with complex protocols or unfamiliar technology. The shortage of study coordinators has spread to investigators and regulatory and other specialists. Hire quality people with the right attitude. Train for skills. Broaden searches to entry-level people, community college programs, pre-meds, etc. Arbitrary requirements, e.g., at least two years of experience, should be replaced with competency requirements and assessed by the site. When appropriate, outsource functions that can be outsourced. Financial Toxicity Most cancer patients must make serious money vs. health tradeoffs. Financial issues increase stress, damaging patient health outcomes. Patients need a comprehensive financial plan but accuracy can be problematic. Study personnel, including investigators, rarely have the expertise or inclination to advise patients about their treatment costs, which vary by patient, be very complicated, and may be unknowable in advance. Patient navigators/advocates/concierges should be able to advise patients on financial issues. Study physicians are often out of network. A five-percent copay on a $50,000 treatment is significant. In addition to treatment-related costs, patients may incur travel, lodging, caregiver, childcare, lost wages, and other out-of-pocket costs. The Medicare secondary payor rule constrains the patient costs that the study sponsor or site can cover. IRBs should not object to even substantial cost reimbursements to patients, which do not constitute income. Given that financial toxicity can hinder enrollment, retention and adherence, study sponsors should consider conducting fewer trials so they can afford better financial support for patients. Identify each patient’s specific needs. Lazarex and other non-profit organizations may be able to help patients with the financial aspects of clinical study participation. Include patients in the design of all aspects of a study that touch them. When hospitals create an oncology grid that provides one study for each combination of cancer type and stage, enrollment in many of the studies can be problematic. The hospitals in a community should, therefore, cooperate on filling the parts of the grid that will be used infrequently. Site Centricity “Site centricity” means seeing a study from the site’s perspective (empathy), giving them a voice in study design, and making their priorities your priorities. You can’t consider a site without considering its community. Sponsor and CRO study personnel need to understand what is happening at the site, e.g., by shadowing a study coordinator. (However, some sites do not allow CRAs (or colleagues) on site.) Studies should employ key performance indicators that reflect site priorities. Hold periodic meetings with personnel from multiple sites. Decentralized Clinical Trials (DCTs) DCTs are not one size fits all. DCTs are not siteless. Use DCTs to reduce patient burden. Beware of using DCT to transfer, rather than decrease, burden. Sites are not adequately compensated for the additional costs they incur in DCTs. Investigators are concerned about their ability to oversee remote personnel (e.g., home nurses) and the related safety and liability issues. Sites are often not equipped to deal with patient technology issues. Fully inform sites and patients and set expectations. Options (e.g., mobile phone vs. paper data eCOA, telephone/email/text/app communications) are essential. Flexibility (e.g., car service for participants without a smartphone, community locations like libraries for Internet access) is essential. Use home visits and online options to prepare for site visits, e.g., QoL questionnaires, tests and assessments. Be creative, e.g., let participants take photos of food rather than logging meals in a diary. Before a study starts, test DCT processes and technology in a protocol simulation with sites and patients. Include someone familiar with the technology at the first patient visit. DCT allows studies to cast a broader net but, so far, it does not appear to have helped improve the principal measures of diversity. Home visits can create numerous issues, e.g., safety for the nurse in a dangerous neighborhood, making a patient with limited mobility feel they have to clean their home, or falling off a chair when replacing a lightbulb at the patient’s request. Keep in mind a lot of study processes are the same with or without DCT. Diversity There is less diversity in oncology studies than in other therapeutic indications. Many or most oncology protocols do not include diversity-related requirements. According to the SCRS Oncology Site Landscape Survey, 36% of oncology departments have implemented diversity-related policies, practices and procedures. Improving diversity requires collecting sensitive personal data (e.g., income) that does not appear related to healthcare, so clearly communicate the diversity objective to patients when collecting such data. Sites with a high concentration of financially well-off, Caucasian patients can contribute to age, sex, gender and other measures of diversity. Do not assume that study coordinators have the skillset or time to conduct community outreach activities. The patients in an oncology study are the study’s biggest cheerleaders. Learn more about the SCRS Global Oncology Site Solutions Summit. About the Author Norman M. Goldfarb is managing director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. He is also executive director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

More than 400 clinical research professionals, including many key industry personnel and decision-makers, recently gathered at the SCRS Diversity Site Solutions Summit in Austin, Texas, for education, networking and a look at the offerings of leading solution providers. Sixty-seven speakers in 18 sessions over 1-1/2 days provided a wealth of insights and practical tips for clinical research sites, sponsors, CROs and service providers, such as the following: Perspectives The clinical research industry lacks a consensus definition of “diversity” or even explicit agreement on why we want diversity (e.g., clinical relevance, commercial relevance, and/or inclusion of underserved populations). Any definition should be quantitative so diversity can be measured and managed in a consistent, actionable and accountable manner. The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act requires clinical studies reviewed by the FDA to include a diversity action plan, including socioeconomic considerations, such as occupation, education, income, wealth and location. Although diversity in COVID vaccine studies has been high, diversity plummeted in other studies during the COVID pandemic. Because increasing diversity in a study population increases variability, it reduces statistical power, meaning that a larger sample size and budget are required. Higher diversity does not necessarily mean that subgroup analysis will be possible. If a small subgroup has a disproportionate number of serious adverse events, establishing causation may be problematic. It may make more sense to assess diversity over a clinical research program with multiple studies. It is unclear whether any study sponsors are doing causal analysis or A/B testing (comparing two options while holding other variables constant) of measures to improve diversity in clinical studies. Populations Caucasians constitute 59% of the U.S. population and 75% of study participants, meaning that Caucasians have more than double the likelihood of enrolling in a clinical study than non-Caucasians. Disabilities and chronic diseases: Over 50% of the adult U.S. population has a disability (including hidden ones). Service animals may be prohibited from site premises, excluding these populations from participating in studies with on-site visit requirements. Sixty percent of the adult U.S. population has a chronic disease. Excluding these populations without a solid scientific reason drastically reduces the available population. LGBTQ+: Ten percent of the of adult U.S. population is LGBTQ and are strong advocates of clinical research because of their community’s history with HIV/AIDS. Nevertheless, HIV prevention medication (PREP) is an exclusion factor in over 50% of studies, including life-saving cancer trials. Regional differences: Diversity means different things in different countries. Race and ethnicity are unusually important in the U.S. Other countries may focus on religion, caste, tribe, national origin or other factors. Intersectional patients (in more than one group) add an interesting twist to diversity. Diversity Landscape Survey In the SCRS Diversity Landscape Survey, 65% of site survey respondents said structured site diversity enrollment capabilities affect the site selection process by a “significant” or “good” amount. 62% of site respondents said their site does not have the support it needs to meet FDA guidance and sponsor requirements. Site respondents rated trial budget support and trial-specific community support as their highest priorities. Respondents indicated only 23% of protocols include diversity-related budget items. However, 53% of sponsors indicated that they plan to offer diversity-related budgetary items in the future, and 23% do already. Notably, survey results indicated that technology has not enabled diverse patient enrollment for most sites (60%). 40% of survey respondents said approximately 40-70+% of their tools and materials have diverse patient preclusive language, meaning diverse populations may not be able to participate if they are non-English speaking or LGBTQ+, for example. In a verbal survey of about 200 conference attendees, only two attendees had ever been asked by their physician to participate in a therapeutic study. Other factors may be responsible for low study participation in underserved populations. Challenges and Obstacles Each dimension of diversity presents its own unique collection of obstacles. Because of their life challenges, retaining low-income patients in a clinical study may be more difficult than recruiting them in the first place. For example, low-income or rural populations may not have smartphones or WiFi access, leading to digital exclusion. Additionally, patients may not be able to use payment cards, and those without a bank account may not be able to cash checks. Taxes on patient payments and stipends remain a barrier for many patients, especially those without a social security number. It is likely a lack of awareness from the U.S. government – not active malice – that makes study stipends taxable, which can disqualify low-income patients from income-tested benefits programs. Sites often need to negotiate for patient travel reimbursement. Note, however, that study budgets do not typically include additional budget for site staff to help patients that may require more support or assistance than others. Also, underserved populations are often ineligible for some studies because their insurance does not cover the costs of a first-line therapy study or the previous first-line therapy that well-insured patients have already had. On the other hand, they can be an excellent source of treatment-naïve patients. While giving investigators discretion on patient enrollment makes sense, it may open the door to arbitrary exclusions based on convenience, prejudice or preconception. Moving Forward & Practical Tips Industry leaders from sites, patient advocacy groups, solution providers, sponsors, CRO and regulatory agencies shared many practical and applicable tips to improve diversity, equity and inclusion in clinical trials. Community outreach came up repeatedly at the conference as the solution to just about every problem. Clinical research sites need to proactively and consistently build trust with underrepresented populations. Sites can collaborate with other sites, healthcare providers, physicians, and community leaders to develop a coordinated community outreach program. Many healthcare institutions have health-disparity programs with dedicated community outreach resources that clinical researchers can leverage. It was discussed that community outreach programs could be funded by a “3% Pledge” program by which sponsors and sites agree to allocate at least three percent of patient recruitment budgets for community outreach. Additionally, Clinical and Translational Science Awards (CTSA) to academic medical centers include community outreach funds. Sites need to move from transactional relationships with patients (study by study) to long-term relationships in which they can build trust. Both study sponsors and sites need a solid diversity plan with measurable goals and accountability. Furthermore, be mindful of the imagery and language used to recruit patients. Artificial intelligence can be used to create racially diverse images for patient recruitment advertisements, although it would reduce the income of photographers and diverse models. Try to put yourself in the patient’s shoes, which requires an in-depth understanding of their situation. Guessing is not an adequate substitute. Most importantly, study design (e.g., eligibility criteria) must consider diversity. Do not mindlessly recycle text from previous studies (#StopTheCopyPaste). Hire diverse people to work at your site and organization. Teach your staff basic conversational and medical phrases in languages your patients speak. Explore funding options with study sponsors, industry organizations and advocacy groups to ensure your site has adequate funding for community outreach, patient transportation, translation services and other resources to facilitate access and inclusion. Assess your site’s knowledge and understanding of the needs of diverse populations with the SCRS Diversity Site Assessment Tool (DSAT), which is being used by more industry sponsors to understand site capacities for diverse recruitment. Learn more about the Diversity Site Solutions Summit. About the Author Norman M. Goldfarb is managing director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. He is also executive director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

An Inside Look from Sites NOW: Diversity in Motion We all understand why the representation of diverse populations in trials is critical to ensuring health equity, accurate data, and patient safety. However, knowing the right ways to engage underrepresented communities remains a challenge for many sites and industry partners. Fortunately, we have seen great strides to break the mold to ensure patients from all backgrounds have informed and equitable access to clinical research. The January Sites NOW discussion explored stories and best practices from site leaders who are building trust in their communities and exceeding diverse enrollment goals in their trials. The panel members included representatives from various backgrounds with unique stories of how they have impacted the patients they work with. Plus, hear inspirational stories as well as actionable advice on how to build trust and access to diverse communities for your clinical trials. Let’s take a deep dive into how clinical research sites can successfully increase diversity, equity and inclusion in their trials. Strategies to Make Connections in the Community Ana Marquez, Chief Diversity Officer for Flourish Research, led her team to become a top global enroller for a study by focusing on building relationships with consulates and community clinics for underserved populations. Her team accomplished this by taking a different approach, like going into small markets and communities in order talk to the community directly. “Get creative and really think about where your target audience is,” she said. It’s not always easy to go out and talk to people we don’t know. That’s why it’s important to find the right person that is motivated and comfortable with talking to strangers. Marquez also mentioned it’s extremely helpful to hire people that look like the community you want to attract. Through Flourish’s community outreach, they met a patient with end stage pulmonary fibrosis. “He didn’t know about clinical research,” said Marquez. “If we would not have been out in the community making these connections, he would have not learned about his options.” He was quickly connected to a transplant hospital where he was able to get a new set of lungs, and has been doing well for nearly 7 years. Preparing for Inclusivity and Accessibility Eden Stein, Executive Director, Patient Insights & Engagement at Centricity Research, shared a story about a patient living in California that was diagnosed with primary membranous nephropathy. His doctors were discussing dialysis and next steps when he started researching online and found out about clinical trials. Stein said the patient was eligible for the trial out of their Arizona site, so they coordinated transportation across state lines. Fortunately, they already had a Spanish ICF and Spanish-speaking staff to increase accessibility for the Spanish speaking population. By taking practical steps ahead of time to make sure language barriers don’t stand in the way of enrolling patients in trials, sites running these studies can make a real difference in the lives of those who are affected by debilitating conditions. One common misconception is that you cannot consent a patient if the PI does not speak their language. However, Ana Marquez stated that any employee that speaks the language can consent a patient as long as it is documented adequately. “We really try to do whatever we can ahead of time to decrease barriers for patients that are not English speaking.” Stein also noted her employees speak 27 different languages across their 45 sites to help break down any language barriers. “Planning ahead to intentionally increase accessibility for these populations is incredibly important. The patient was able to join the study at our site, and was with us for six months while a site that was closer to his home got started. We were able to delay dialysis – a huge change of life for this patient.” Training a Diverse & Inclusive Workforce Dr. Fabian Sandoval, President & CEO of Emerson Clinical Research Institute (ECRI), said his organization has been focused on diversity since the very beginning. They’ve been successful in increasing diversity within their therapeutic areas, while also expanding their reach through TV shows and social media initiatives. Currently, they reach over half a million people every Saturday with plans to expand their TV show across the country. However, it wasn’t always easy. Dr. Sandoval mentioned it was an uphill struggle to gain traction with their TV show and social media for the first two years. Now, they have established rapport with their communities and are focused on building a diverse workforce. Recently, ECRI developed an in-person and virtual internship program in partnership with a local university. The program teaches students the value of becoming a study coordinator and principal investigator while learning the history of clinical research as well as practical understandings of EDCs, patient consent, community outreach, and the FDA. Once complete, the students can apply for a longer internship or job. Dr. Sandoval is even helping his staff learn basic Spanish so they can better communicate and understand their Spanish-speaking patients. “I tell them it’s never too late to learn another language,” he commented. Flourish Research also developed a Diversity Workstream, which was broken down into two subgroups. One of the groups deals with diversity and inclusion in the workplace because people want to share their stories, they want to be celebrated and it’s important to understand their cultural background. “It’s two different things that we’re dealing with – patient diversity and also diversity and inclusion in our in our workforce.” Mohammad Millwalla, CEO of DM Clinical Research shared that “diversity has become a mission, not only from the industry standpoint but also internally.” With more than 600 employees, DM Clinical has created a staff community that is 74% diverse – and that’s just the starting point of their diversity initiatives. The Value of Brand Ambassadors Last year, DM Clinical Research had a study that hoped to enroll 1,000 diverse participants. The organization knew that just advertising is not going to make it happen, and they needed to do community outreach. During their outreach at multiple health fairs, they found an amazing individual named JR, who was African American. JR decided to become an ambassador for DM Clinical Research and suggested they join him at his ballroom dancing classes. JR then led a lunch and learn with the DM Clinical team sharing information about clinical trials where they enrolled 17 out of the 23 attendees. “JR has helped us make different videos for better awareness of inclusion and diversity for the African American community, and that has really served as well,” added Millwalla. They then duplicated this strategy in other locations, which were all a success. “What we learned from that idea was that if you want diversity, then you’ve got to listen to the people, let them lead, and let and help them operationalize their story and their idea.” Although the ambassador program was started in 2020, it didn’t really take off until they had established relationships with key ambassadors throughout their regions and communities. Their ambassador program features an interactive community-building app where ambassadors can communicate with one another internally and externally. Taking the First Step It’s important to keep in mind not all sites may have the infrastructure or resources to do community outreach. How can sites take the first step to enable diversity and inclusion within their organizations and trials? First, do intel in your communities. Know your community demographics so your enrollment can reflect the availability of different participant groups in your area. Your staff can be your champions. Have them reach out to their friends, family, and acquaintances and educate them about clinical research, and ask them to be involved in some way. Remember it’s not just about being a research institution – it’s also about being a health advocate. Clinical trials aren’t just about finding new treatments; they’re also about giving patients hope and improving their quality of life. Sites can also reach out to organizations like Latinos in Clinical Research or Black Women in Clinical Research that can help provide ideas and strategies for better community engagement. Work with local physicians. Sponsors and CROs can also appoint a diversity ambassador or liaison that can train sites, provide funding and help them break into new communities. By creating a space for diverse voices to be heard, we can learn from each other and identify ways to improve. Eden Stein’s organization, Centricity Research, created a diversity advisory council to talk about what their community does, how they feel about clinical research and break down some of those stigmas. “We need to do a better job with defining what diversity is; it’s not just diversity, it’s also inclusion,” said Marquez. It is through initiatives like these that we will be able to create a more equitable research environment and improve patient experiences worldwide. Join us at the annual Diversity Site Solutions Summit as we share more resources to advance diversity, equity, and inclusion in the clinical research industry. The Sites NOW program is designed to provide a platform for discussing stories and solutions for site success. Throughout the one-hour session, panel members discuss hot topics impacting the clinical research industry and best practices that organizations can use to prepare. Sites NOW is a space for all of us – researchers and practitioners alike – to come together and share our thoughts on how we can enable greater site success and sustainability. Everything discussed during the program informs further research down the line in white papers, articles and sessions at upcoming Summits. Register for the next Sites NOW and watch the meeting recording below.

By Velocity Clinical Research Clinical trials — especially high-volume trials — are primarily designed to collect quantitative data. Collecting and reviewing qualitative data and experiential feedback from trial participants is rarely prioritized. Before being acquired by Velocity Clinical Research, Meridian Clinical Research built an in-house surveying system to elevate the participant’s voice. The system, which is largely automated, collects ratings and feedback from clinical trial participants across 30+ research sites. A real-time dashboard shows responses and ratings by site, and alerts site staff and leadership team members of potential issues when negative feedback is received. This whitepaper highlights key takeaways from 9,000+ responses (7,200+ unique) collected across 11 states since August 2021. Meridian Clinical Research discussed the white paper on the SCRS Talks podcast. Listen below!

By Clinical ink Technologies come and technologies go. But how do you know when it’s time to abandon a familiar system for the latest innovation – especially when it involves a significant investment? Drug Sponsors are faced with that very question now when it comes to electronic data capture (EDC) systems. When – and how – should they begin relying instead on solutions that allow trial data to be captured directly from the source, at the moment of inception, for storage in a flexible eSource ecosystem? There are strong arguments to be made for Sponsors to begin making a gradual transition now. As their decisions ultimately affect how investigators and other site staff will work day to day, it’s worth understanding what they’ll be considering… EDC Systems Have a Shelf Life Two decades ago, Electronic Data Capture (EDC) systems were heralded as the answer to a very specific need at clinical trial sites: they allowed for electronic versions of case report forms. Although in recent years EDC vendors have attempted to support the capture of other forms of electronic trial data, the process is complex and far from seamless. It is time-consuming and costly, making the final application impractical and inefficient. The inescapable fact is that EDCs were never meant for more than that original, narrow application. And tasking them with more – to accommodate the broad range of electronic data used in clinical trials today – has required makeshift solutions. Even so, as trials become increasingly decentralized and aim to capture data directly from patients, EDC systems are rapidly becoming insufficient; they cannot, and were never developed to, handle the volume and continuous nature of data coming from the more advanced data sources being used in trials today. An EDC might be able to ingest a simple data stream from a wearable such as the patient’s total step count in a day. However, EDC systems are wholly inadequate for ingesting, securing storing, and analyzing the complex data streams that more complex trials, including ones that necessitate digital biomarkers technology, produce. Such vital data might include an assessment activity, passive data streams, or cognitive testing, for example. The Advantages of Direct Data Capture Direct data capture (DDC) software can capture trial and patient source data that is initially recorded in an electronic format as eSource data. These eSources include: · Telehealth visits · The eConsent process · Laboratory results · Electronic Clinical Outcomes Assessments (eCOA) · Electronic Patient Reported Outcomes (ePRO) · Sensors and wearables data · Digital biomarker analysis technology · Patient engagement platforms What’s more, the software is flexible enough to gather information from various formats, including videos, images, voice and hand-written notes. Ideally, eSource data are ingested into a unified data platform to support analytics within and across studies, regardless of how it is captured or by whom. DDC systems, having been designed to support modern trials that may have decentralized elements and aim to be operationally streamlined, offer a host of benefits to Sponsors, contract research organizations (CROs), investigator sites, and patients themselves. Sites that have the good fortune to begin using DDC systems will benefit from: · Reduced administrative burden. There are no paper-based sources and no need for transcription. This eliminates duplicate efforts, requires no source data verification (SDV), and results in dramatically fewer data queries. · Support for a patient-centered journey. All data points from patients are captured directly, in real-time. · Improved visibility and management of data. This extends across visits, devices, sensors, telemedicine and digital health technologies and eliminates the delays and data inaccuracies associated with paper records. · A cohesive audit trail across systems, users, and data sources. · Compliant long-term storage. Trial data can easily be stored and results duplicated for as many years as required by regulators. Sponsors, for their part, will enjoy: · Instant access to data for increased compliance and more effective oversight (as compared to an often 60-day time lag with data captured in EDC systems). · Higher-quality data owing to fewer opportunities for human error. · True central monitoring, as source documentation is reviewed remotely, eliminating the need for monitors to travel to sites. · Improved compliance and pharmacovigilance. With data collected from any source and stored in one data set, research teams are empowered with real-time visibility and context for immediate monitoring that ensures patient safety and compliance with regulations. · Peace of mind, knowing that they are making insight-based decisions from complete, timely, accurate trial data. A Recommendation: Gradual Adoption Considering that EDC systems are supporting trials that are underway and that adopting new technology requires an investment in software and training, it would be advisable for Sponsors to “sunset” EDCs over time, gradually converting to DDC for upcoming trials. Then, over time, as DDC is applied to all new trials, the old EDC systems will gradually be used in fewer and fewer trials and take their place in the technological dustbin. Admittedly, even a gradual transition will call upon site staff to learn new software, but it will be a means to an end that portends dramatically less administrative work for sites and a better trial experience for all.

By Queen Adaugo Ohandjo, Ph.D, MSCR Founder, Proof Clinical ResearchSite & Patient Experience Advocate Operational efficiencies, when properly leveraged, are a key opportunity in clinical research to resolve bottlenecks in all aspects of clinical operations. For example, there are still operational inefficiencies with site-managed data synchronization, thus causing a break or bottleneck in the feedback chain. Fortunately, many technology partners are already doing their part in prioritizing operational efficiencies. Here at Proof Clinical Research, the operational efficiencies that we have experienced while advocating for patients and sites in the clinical industry are centered around patient data capture, shared investigators platforms and the digitalization of clinical trial documents like eProtocol, eConsent and eISF. The impact of these solutions and systems has helped to transcend the clinical research landscape, but a full-scope transformation is necessary if we are to create and sustain an inclusive and equitable clinical industry that transcends time. Establishing Efficient Clinical Workflows According to site and patient feedback received from our grassroots efforts, the consensus is that operational efficiencies should be defined by clinical workflows that enhance the survivability and successful outcome of clinical trials managed by site personnel. The Clinical Trials Operations Branch in the Office of Clinical Research at the NIMH developed a framework for assessing the operational complexity of clinical trials. This complexity is based on potential operational challenges presented in the planned research. According to NIMH, the goal of the assessment is to evaluate the operational aspects of a clinical trial in synchronization with the study team’s resources and capacity. In addition to successfully enrolling eligible participants in a study, a clinical trial relies on having enough retention of participants through study completion to have the statistical power to answer the proposed research questions. The Office of Clinical Research at the NIMH highlighted that there are numerous factors that contribute to study dropout and follow-up completion rates. Some factors are controlled by the study team while others factors are controlled by a population that is more clinically unstable than expected. The life cycle of clinical operations begins with patient engagement. All stakeholders should be mindful of what is being asked of clinical study participants in terms of the frequency and complexity of clinical procedures. This is a necessary step to assess if participants will be willing to enroll and remain engaged for the duration of a study. Data Collection & Management Another aspect of the operational evaluation relates to data collection, coordination, and management. A feedback loop is necessary in order to eliminate bottlenecks and redundancy. Ultimately, attracting and retaining participants in the research of new medicines, therapies and interventions are becoming an industry and non-industry-wide effort. We need not be complacent about integrating solutions from other industries in order to reach a wider audience whose attention and interest in clinical trials have been clouded with horrific and non-ethical experiences. Subsequently, a comprehensive operational review allows study teams to make more informed decisions about whether a team has the staffing, resources and procedures in place to run a trial successfully from inception. This informed decision should be substantiated with real-time reports from integrated and unified clinical platforms. By reviewing factors that contribute to operational efficiencies, sites and patients are better positioned to enhance the stewardship of the clinical trials it supports and participates in. The digitalization of clinical trial start-up processes into an integrated or unified clinical environment has resulted in favorable outcomes, however much more is needed to ensure a successful and positive patient recruitment experience. Unified platforms that connect patients, sites, sponsors, and partners in a secure and scalable cloud environment by reusing, recycling and standardizing data ultimately help to bring life-changing medicines to those who need them most. The objective is not unified vs integrated; the objective should be solutions that integrate all the functionalities required for a clinical study from planning to closeout. This includes, but is not limited to: a solution that facilitates hybrid, on-site, off-site and remote teamwork. a solution that is geo-regulatory compliant. a solution that is adaptable to epi-financial outliers. a solution that is built on intelligent reporting capabilities. a solution that incorporates natural language processing and cultural nuances. a solution with synchronized feedback into clinical workflows. Enabling Trial Diversity Furthermore, when utilized appropriately, we know that technology can be instrumental in accessing and managing a diverse patient representation in trials, but there are still lessons to be learned regarding how to better serve sites and patients in an inclusive manner. Discussions with patients and sites inform us that the digitization efforts have to expand beyond our clinical industry and begin to collaborate across non-clinical industries that share similar outcomes and patient profiles with clinical trials teams across the globe. The push for good medicines begins with a better understanding of the patient’s lifestyle, site-patient relationship, patient cultural awareness and community-centered participation. Partnership with communities and diverse patient representation are critical to earning and maintaining trust in the clinical research and healthcare industry. When diversity and inclusivity have been met, then ensuring positive community impact and equitable uptake of new medicines, therapies and interventions should be the primary objective of all clinical trial stakeholders. A community-centered participatory research (CCPR) approach that intentionally accounts for the social and local needs of engaged partners (patients and sites included) will be necessary to enhance and create solutions that prioritize operational efficiencies in a non-biased manner. A patient-recommended CCPR blueprint includes solutions integrated with: Cultural sensitivity & specificity: applications that enable and promote positive and effective interaction with diverse cultures. Knowledge training: applications that focus on providing patient and site partners with the content and process know-how needed to retain participants’ full and robust engagement in clinical research activities. Supportive measures: applications that provide facilitating tools, devices, platforms, or materials that support full engagement in clinical research activities. Clinical Research Sites & Patients Drive Intentional Changes There is a huge opportunity for site and patient advocates to educate stakeholders on what works well in the environment and community where research is being conducted. Sites are the epicenter of the clinical trial process. As a result, there is an opportunity for sites to drive intentional changes into sustainable and successful clinical operations. Site feedback on targeted outreach, opportunity marketing, inclusive applications, and participant selection processes creates a valuable atmosphere whether in an offsite, on-site, remote or hybrid setting. Site and patient advocates streamlining the message to all stakeholders through channels (such as advocacy channels, social network channels, and peer-to-peer channels) are necessary to reach underrepresented populations. In summary, there is a huge opportunity for site and patient advocates to educate stakeholders on what works well in the environment and community where research is being conducted. By working closely with advocacy and existing social network groups, key stakeholders begin to build trusted pillars within the community and engage with patients in the contexts that are familiar to them thus enhancing operational efficiencies and establishing clear practices for how the future of clinical research should be operationalized. For example, during the planning stage, the utilization of mobile and/or web applications that identify and test potential community outreach strategies, and develop peer /clinical navigator programs, community-centered practices and support resources should be integrated into unified platforms or serve as a stand-alone add-on. This approach will help identify and test potential operational strategies, identify bottlenecks and mitigate financial losses due to inconsistent forecasts well before millions of dollars are invested in a particular clinical study. References Sharon L. Smith, DNP; Galia Siegel, PhD; Ashley Kennedy, PhD. Assessing the Operational Complexity of a Clinical Trial: The Experience of the National Institute of Mental Health. Clinical Researcher—March 2020 (Volume 34, Issue 3) Elizabeth Cope, Ph.D., M.P.H. Prashila Dullabh, M.D. Michelle Johnston-Fleece, M.P.H. Claudia Grossmann, Ph.D. HSR Resources & Methods Research Ethics & Governance Patient & Consumer Engagement Health Equity. Mar 01, 2022 TransCelerate BioPharma Inc. Seven ways to diversify patient populations in clinical trials. https://www.transceleratebiopharmainc.com/seven-ways-to-diversify-patient-populations-in-clinical-trials/ 08/03/2021 Reeshav Mittal, BDS, CCRA, CCRP. Cloudbyz for Association of Clinical Research Professionals. Unified Clinical Trial Management Systems: What They Are, Why They Matter, How to Choose Them., March 30, 2022

By Andrew Gerrard, Product Trainer, Greenphire, the global leader in financial lifecycle management for clinical trials. At the 2022 SCRS Global Summit, I had the opportunity to speak on the panel, Advancing Technology with Attention to Site & Participant Burden. While I typically conduct trainings live online, it was rewarding to be with sites face to face, hearing directly from them about the ongoing burden of frequent technology trainings, as well as their thoughts on what creates the ideal training experience. These insights are valuable for us all. Below are the top takeaways to consider when training site staff with various clinical trial technologies. 1. Provide training in different formats Considering the fundamental fact that not every person learns the same way, to get the most out of your training, you need a multi-pronged approach. Some people prefer videos that can be watched at home when it’s convenient for them while others want hands-on experience and an opportunity to ask questions from experts in person or access resources via tips & tricks built right into the application as they go along. By providing multiple avenues for consuming educational materials and learning how to use a given platform in a way that best suits the individual, we set site staff up for success when it comes to easy adoption and overall satisfaction with the technology. 2. Adaptability for existing knowledge or prior experience Many of the most used technologies in the industry have been leveraged across a multitude of studies at sites around the globe, therefore site staff may already be familiar with the fundamentals of a technology when they join an existing site, so it is important to avoid duplicating trainings if those were completed elsewhere. This again echoes the notion that one size does not fit all when it comes to training, and the value of providing site staff with several options when it comes to how they would prefer to learn a technology. 3. Ongoing access to guidance and support No matter how robust your initial onboarding training was, there is always room for improvement. With so much time passing between the day you conducted an informative session and now- when users are using these tools daily – it can be easy to forget some of those little tips or tricks that may help make things go more smoothly during study entry. That’s why it’s a good idea to have a solution that continues to provide tips and tricks and pop-up reminders for quick answers to questions that may arise during the study. These on-demand support features empower sites to easily find many of the answers they need without escalating support tickets or wasting valuable time. 4. Accommodating time zones and schedules Since many studies include sites that are located all over the globe, to make sure that site staff can get the most out of their learning experience, it’s essential to offer a schedule of live trainings so they can meet experts at times convenient for them. This approach not only welcomes more coordinators to join live sessions and ask questions, but also provides the opportunity for a trainer to address any country or region-specific variations that might come into play when using the given technology. 5. Providing and welcoming feedback Feedback isn’t just about the negative stuff. Constructive comments are as important in determining what worked well, and how we can improve our training or technology for future use. Welcome individuals to give their opinions on the tech so that the solution can truly become user-centric and provide real value. At Greenphire, this feedback is incorporated into our product innovation roadmap. As you can see, there are many factors to consider when training site staff for your clinical trial. You’ll need to think about the format of the training, how to adapt it for different levels of knowledge or experience, and ongoing access to support. Additionally, time zones and schedules can be a challenge, but feedback is essential. These are just a few considerations – what are some others that you’ve had to consider?

In Response to the Open Letter to Sponsor and CRO Colleagues Regarding the Workforce Retention and Inflationary Pressures Affecting Clinical Trial Sites As a large sponsor in our industry, we are acutely aware of the unprecedented challenges our clinical research site partners are facing with the attrition of experienced staff. We acknowledge that a recent SCRS site survey indicates a 35 to 61 percent turnover rate. Our company recognizes the importance of supporting clinical research sites while building the next generation of diverse talent as an imperative to maintain the clinical trial ecosystem. We hope to inspire others by sharing some of the ways in which we are investing in these efforts. We sponsor an extensive R&D internship program each year. In addition, we: Continue to build our entry-level program (i.e., no experience required) hiring college graduates into entry-level Clinical Trial Coordinator roles within our operations team. Serve as a premier member of the Association of Clinical Research Professionals (ACRP) Partners Advancing in the Clinical Research Workforce (PACRW), a multi-stakeholder consortium supported by sponsors, CROs, investigator sites, academic institutions and regulatory agencies, targeting workforce growth and diversity. Recently, ACRP released “Ready, Set, Clinical Research!,”™ a flexible toolkit that is being used across our teams to raise awareness of clinical research as a profession to high school, college and other student groups. Provide access to ACRP Clinical Research Coordinator Core Competency training for clinical research sites located in historically underrepresented communities and ACRP’s entry-level training for students interested in the clinical research profession. See press release. Participate in the Employer OneTen program, a coalition of industry leaders committed to cultivating opportunities for non-degreed Black talent in the United States. Thus far, we have hired 21 people to begin a career in clinical trial operations in our data management team. Our company is on track to hire 100 people from underrepresented groups in the Philadelphia area by the end of 2023. Participate in the Education Committee of the Society for Clinical Research Sites (SCRS), which provides guidance and oversight of all SCRS educational activities and identifies additional training program opportunities specifically for research sites.   Through our vendor partners, we also continue to provide site Study Coordinator resource support to help mitigate enrollment gaps and focus on community outreach and patient recruitment. We recognize that there is much work to be done in creating the next generation of clinical researchers but there is strength in numbers. That’s why we, along with our industry colleagues, must continue to invest, support and share best practices on how to build and diversify the clinical research workforce. As always, our company is open to collaborating with sites and others in the industry to help in the development of future talent.

Underrepresentation in clinical trials presents serious challenges to public health.  By Curebase According to the 2021 U.S. Census Bureau, Non-Hispanic Whites represent 75.8% of the U.S. population, Hispanic/Latinos represent 18.9%, and Black/African Americans represent 13.6%. Yet, according to the FDA 2020 Drug Trial Snapshots, on average, Non-Hispanic Whites comprise 75% of traditional trial participants, while Hispanic/Latinos comprise only 11% and Black/African Americans comprise only 8% of participants. Recent guidance by the FDA emphasizes the importance of trial participants accurately reflecting the real-world population in an effort to ensure that all are properly represented in clinical research. Otherwise, any conclusions may portray a skewed public health message that can further healthcare inequities. A decentralized approach to clinical research leads to greater diversity in clinical trial participation by using local, virtual, and at-home care models.  Across our partnerships, clinical trial makeup has had up to 50% more Non-White participation, including up to 67% more Black/African American participation. This can be attributed to the fact that decentralizing clinical trials addresses major obstacles to equity and access by removing barriers for patients such as geographic location, distrust of healthcare systems, accurate collection of patient symptoms, pain points, and outcomes, and much more. Removing geographic barriers for patients in healthcare through virtual trial sites Most traditional clinical trials are run at hospitals, academic research centers, or universities, therefore only people with the ability to get to the facility can participate. Many trials also involve frequent visits to the physical site location. This requires participants to afford numerous trips on private or public transportation or live within a commutable distance. Obviously, this prevents many patients from participating and providing valuable data. Incorporating virtual clinical trial site models allows researchers to expand patient access to these trials.  With this model, patients across the globe can contribute to the same study without leaving their homes or traveling further than their local urgent care or physician’s offices. Concurrently, researchers can gain key insights into how different lifestyles and environments influence health and medication effectiveness – this type of data can also be a key element to understanding and fighting against disparities and inequities in the healthcare ecosystem.  Building patient-provider relationships As we have seen quite clearly with the rollout of the Covid-19 vaccine, many people are wary of the American healthcare system. The Tuskegee Study, for instance, is one example of historic abuse of minority groups causing ongoing generational trauma. To overcome this systemic issue, patients need to feel that they can trust the clinicians collecting their data and developing their treatment plans. Utilizing patient-centric software designed to help providers focus on building patient relationships, physicians become researchers just by treating the patients they see every day. Not only does the physician-centric model encourage diversity in trial participants but it also provides opportunities for patients who might not otherwise hear about clinical trials. Represent the underrepresented with us While underrepresentation in clinical trials continues to be an issue, there is a general consensus among the life sciences community that we need a transformation. But how do we make sustainable and meaningful change? At Curebase, we recognize that decentralized clinical trials are the future of R&D. Every day, we are innovating and improving access for physicians, patients, and researchers. We are on a mission to ensure every patient can participate in cutting-edge medical research. We believe that including patients with varying backgrounds, experiences, and identities in clinical trials is essential for advancing healthcare. Decentralizing clinical trials can address healthcare disparities across race, gender, and ethnicity by increasing equitable access and broadening the representation of clinical trial participants while collecting quality real-world data. Read more about diversity in clinical trials: Supporting Women’s health: Addressing gender disparities in clinical trials

Observations from the SCRS Global Site Solutions Summit By Kelly Brown, Chief Marketing Officer, Teckro At this year’s Global Site Solutions Summit hosted by the Society for Clinical Research Sites (SCRS), there were a few stand-out themes – workforce constraints, budgeting and contracting challenges, and the proliferation of technology in clinical research. It wasn’t just conversations about too much technology that struck me. It was the visceral, emotional expression of how this technology is affecting people. For example, one of the main stage events was called “Tech or Terror: What Does the Exponential Increase in Technology Mean to Current & Future Operations of Research Sites?”. I’ll come back to some observations from the session in a minute, but the word choice of terror is a good example of what I mean about strong emotions. Someone from a site network told me, “If (name redacted) were a building, I would light it on fire.” I’m not about publicly shaming anyone, so I’ll keep the vendor’s name to myself. Yet again, this is an example of anger and fury at things that are making life harder for research staff. What worries me is that “technology” is a catch-all category for anything and everything digital. If we peel back the onion a bit, there are a few things that are muddying the waters when it comes to clinical trial technology. Passwords Galore Several people during the conference said how they wished there would be mergers and acquisitions because there are too many clinical trial technology vendors. I haven’t done a scientific analysis of the per capita vendors compared with other industries, but certainly there are a lot and constant newcomers trying to join the party. Innovation comes by trying to make things better, but better is in the eye of the user. More vendors trying to innovate with solutions that improve clinical trial operations isn’t a bad thing. However, the unintended consequence is the number of different systems that research sites must manage by study and across sponsors. The proliferation of portals to log into and passwords to remember is at a point that is unsustainable for sites. One solution I heard debated will make IT security people cringe: to have non-expiring passwords. I seriously doubt that muting password security gets to the heart of the problem and likely will introduce more issues. Electronic Is Not Disruption The clinical trial industry is an obvious target for disruption, which is why there are so many solutions out there. But one of the observations made during the “Tech or Terror” session is that, by and large, clinical trial technology is simply making physical, manual processes electronic. There really isn’t a substantial improvement in how things are done – so to “modernize” them with technology doesn’t really fix the core underlying issues. Now, this “Tech or Terror” session was held in a ballroom and there were probably 100 people or more in the audience. The best indication of just how slow things are to evolve was about half of them are still using fax machines. Remember, fax machines were once innovative… decades ago. Clinical trials are still dominated by paper-biased processes, which is a bit of a paradox because your average physician is rarely dealing with paper outside of research. Yet, I talked with an investigator who said he printed every electronic communication to sign and include in his investigator site files. During a session that I moderated about remote monitoring, there were discussions about documents being printed and then held up to a video camera for CRAs to visually inspect remotely. Patients, Not Techies Recall that workforce shortage was another topic of the conference. Just like many other industries, there simply aren’t enough qualified people. Research staff are being lured away for better pay, and CRAs are leaving the industry at an alarming rate. So, it was shocking to me to hear that sites are investing in full-time positions to deal with tech support issues that patients have with their devices and apps. It’s no wonder that one of the research site owners that I talked with was adamant that he didn’t want anything to do with technology. He was lumping everything together and did admit his frustrations were with patient-facing technology. Not all people in clinical trials are tech savvy – or even appreciate technology. There are clear use cases for patient solutions, such as capturing real-time data and simplifying the patient experience. However, the burden on sites to troubleshoot their patient technology is untenable. Research Sites Take the Driver’s Seat Technology is here to stay. Research sites recognize this and are hiring IT support. Some are also carving out IT budgets and deciding their own tech stack for themselves. As a business, this makes absolute sense. Sites are pushing back. Some are refusing to use sponsor or CRO-mandated technology. Others are increasing the pass-through costs of technology training and enablement. For example, sites are spending between 10-20 hours per month per trial on training related to DCT technology, according to the annual SCRS site survey landscape. Sites are also declining studies due to unacceptable budgets, which also goes to the budget and contracting discussions during the conference. In a risk-averse industry, the status quo is safest. And paper is the “safe” choice when it comes to audit and inspection readiness – or so the belief goes. This then lends itself to clinical trial operations stuck between modern and antiquated – and research staff caught in the middle. Giving sites the flexibility to decide their own technology is just one step in the right direction to advance drug development and clinical trials, ultimately better serving patients. What’s Next At Teckro, we support the SCRS initiatives to help navigate approaches to advancing clinical trial technology. To that end, we will be a major contributor to the new SCRS Tech West conference in June. We look forward to leading discussions that will align technology with the needs of the clinical research industry and what sites really want. We encourage as many stakeholders as possible from sponsors, vendors, CROs and sites to work with us and SCRS. Read more site-related content

In October, SCRS came together with more than 1,200 clinical research professionals at the Global Site Solutions Summit to commemorate 10 years of advancing site success. We also celebrated forward-thinking organizations creating innovative solutions and partnerships advancing the clinical trials industry. In the November Sites NOW discussion, 2022 SCRS award recipients highlighted the initiatives and strategies that helped them stand out and earn well-deserved recognition. Putting patients at the center In 2021, DM Clinical Research decided to implement data-driven decisions to enrich the patient journey.  Patient-focused practices were already a core value of this year’s Excellence in Patient Centricity award recipient, DM Clinical Research, but they wanted to take that value a step further by making it a strategic goal. Hera Arham, Director of Marketing & Patient Engagement at DM Clinical Research, shared that they first worked to identify roadblocks and pain points their patients experienced. Through a sophisticated tracking system, they created an internal dashboard to identify issues at each site with the goal of changing staff behaviors to be more mindful of the patient experience. “Using data to operationalize patient centricity is the key,” said Arham. “How do we innovate to become a patient-centric company if we don’t have the data and tools?” DM Clinical then created a dedicated patient engagement team that was responsible for assessing, improving, monitoring and reporting on the end-to-end patient experience. Additionally, DM Clinical established an additional customer support team to manage real-time calls for all patient inquiries. This team answered questions ranging from transportation to the clinics, trial compensation, communication with staff, and even eDiary or compliance issues. Within the first six months, the dedicated team answered more than 17,000 phone calls that would have been missed and resolved 1,000+ patient issues in real time. Gathering patient feedback was also critical for DM Clinical. Patient input was collected through a combination of automated surveys and spot-individual interviews after each interaction. This allowed unfiltered contact with patients that were enrolled or considering enrolling. Scorecards were created for each site that measured Google reviews, focus group data, and survey data. The scorecards were reviewed by both site and leadership teams to determine solutions needed for improvement. Patient retention and referrals increased after implementing these practices. “Our shared-decision making helped us create a more patient-centric approach to identifying common trends and unique situations that impacted the way participants perceived research, DM Clinical, and medicine in general. We knew changing the culture within an organization to be more patient-centric meant that we’d need to support the change through reliable metrics and KPIs. Real data helps identify blind spots and track progressive improvement. At DM Clinical, we knew one thing to be true – we all needed to become patient advocates,” said Arham. Moving the needle in diverse community outreach and recruitment Javara, recipient of the Site Patient Recruitment Innovation Award (SPRIA), developed a recruitment plan to reach a variety of patients through different mediums, including social media advertising, doctor-to-patient email marketing, direct mail and newspaper ads. “Innovation isn’t just technology; it’s about taking existing processes and making them better,” shared Mike Clay, Chief Operating Officer at Javara. The recruitment efforts prioritized community engagement and human interaction. They worked with the non-profit organization Greater Gift to support this component. Greater Gift’s mission is to increase awareness of clinical research, especially among underrepresented communities. This partnership allowed Javara to develop relationships within diverse communities. By developing relationships and cultivating a community before recruitment efforts, the patient population was more receptive and in turn, Javara and SouthCoast Health were able to exceed enrollment for this study and increase diverse patient participation. Increasing the clinical research talent pool As we learned in the August 2022 Sites NOW discussion, there is a significant gap between the number of jobs available for clinical research coordinators (CRCs) and the number of qualified staff to fill those positions. To address this, Site Tank Award recipient UC Davis Health School of Medicine – Clinical and Translational Science Center (CTSC) developed a program to train the next generation of clinical research staff in 16 weeks. In collaboration with local community colleges, Medix, and UC Davis Health’s Diversity and Inclusion program, a pilot training program was launched to address the persistent shortage of CRCs and increase diversity of the clinical research workforce. The comprehensive training program also opened a pipeline to STEM careers for people historically underrepresented in these fields. Stipends, internships and shadowing opportunities were provided. This was the first comprehensive CRC training program administered by a public-private partnership. The program was unique in that it offered a combination of classroom learning with workplace exposure to clinical research processes. After completing the training, Medix helped place the clinical research coordinators in open roles with UC Davis or other organizations. UC Davis plans to expand the program by collaborating with more colleges and organizations nationwide. Site-centricity from the CRO perspective As the 2021 and 2022 recipient of the Eagle Award, PPD, part of Thermo Fisher Scientific, has been prioritizing site-focused approaches to everything they do. A more recent initiative by PPD has focused on improving training for sites that are new to clinical research and help those sites gain experience to earn more trials. As more sites adopt decentralized elements in their trials, PPD actively requests feedback from sites on how to make DCTs better overall and acts on that feedback. Diversity is another critical need for the industry that PPD is prioritizing. For diversity efforts, they have been working with sites to determine their needs for better diverse enrollment and developing programs to adapt to those needs. What can sites do to stand out and be noticed by CROs? Lisa Dyment, Senior Director of Site Collaborations at PPD, part of Thermo Fisher Scientific, encourages open dialogue and staying in close contact with the sponsor and CRO. “Have open dialogue with your points of contact at the sponsor and CRO. Be very honest about your enrollment objectives and what you can realistically achieve. Give feedback. Let us know what you like and don’t like about the study and challenges you might be facing. As an intermediary, we may not always have the power to make changes in a study, but we can definitely commit to passing the message along,” added Dyment. Establishing consistency at the sponsor level After the world was turned upside down from the pandemic, 2022 Eagle Award recipient Merck decided to get back to basics, working to analyze and understand the areas where sites needed support the most. Merck asked their sites about their pain points and then developed a strategy to step up to those needs. Sites have consistently asked for single points of contact for both CROs and sponsors, and Merck delivered in an especially critical area: budgeting and contracts. Merck appointed one person to negotiate budgets and contracts with each site, so that sites would only have to communicate with one person. Another initiative kept CRAs at the same sites to establish relationship, cadence and familiarity. Additionally, Merck created a dedicated, real-time technology support team to help sites with onboarding and implementing new technologies. Amplifying the voice of the sites Viviënne van de Walle, the Christine K. Pierre Site Impact Award winner, has been a huge advocate for SCRS and clinical research sites for decades. As an SCRS Leadership Council Member and European Site Solutions Summit chair, she is a remarkable leader and voice for sites around the world. Improving lives of patients is at the heart of Viviënne’s work, and improving processes at sites and throughout every stage of clinical research is a large part of that. Vivienne shared that clinical research stakeholders are understanding each other’s sides of the story by coming together often and communicating openly through mediums like Site Advocacy Groups, online and in-person events, and the SCRS online community. Congratulations again to all of the 2022 award recipients and finalists! Learn more about each award at sitesolutionssummit.com. Watch the replay of the Sites NOW discussion here:

By Curebase How Co-Creation with DCT Vendors, Sponsors, and Sites Makes Participation in Decentralized Clinical Trials Easier For Sites In this guide, we reflect on the relationship between decentralized clinical trial vendors, sponsors, and virtual, traditional, and hybrid trial sites in the design phase of clinical studies. This comprehensive review illustrates how different site models can and should participate in clinical studies and how sponsors and DCT vendors can design studies to include site-friendly elements. The relationship that exists between sponsors, DCT vendors, and sites and how this relationship can be optimized for more mutually beneficial partnerships. The need for implementation of site support systems while participating in clinical trials and the ways in which DCT tools can make participation more frictionless for site staff. How site voices are missing in study feedback which can be used to better understand the burden sites face and to properly identify the proper site models needed for studies. Technologies and services DCT vendors can offer sponsors to better facilitate feedback cycles and support systems for sites participating in their trials.

By Kyle Given, Executive Vice President of Account Management, Transformative Pharmaceutical Solutions Whose favorite activity in a clinical trial is answering data queries? I would take a guess that the answer is a resounding “not me” for almost every site resource that has ever been involved in a clinical trial.  So why, then, is data management such a significant, and aggravating, part of the study coordinator’s responsibilities? Well, let’s start with the fact that patient data is voluminous and highly variable within and across patients. It is hard to keep it all straight, especially if a site may not be trained on certain data management concepts or provided with the same tools necessary to visualize that data.   Also, given resource constraints at many sites, data operations are often deprioritized, which builds up a backlog of data cleaning and potentially more queries. On the other hand, having high-quality, consistent, and reliable data is essential to answer each protocol’s efficacy and safety objectives with a high level of scientific rigor. Let’s start with the first issue, available resources. Most study coordinators are clinically trained – not trained to be data experts. This does not mean they do not have an awareness of the logical ways that clinical data interact, but they may not have the same level of knowledge and experience as a data manager that ultimately oversees the data quality in a clinical trial.   More importantly, clinical trial budgets often underestimate (or largely ignore) the amount of time that will be spent entering, curating, and cleaning patient data. It’s almost impossible to anticipate this volume of work before a trial starts. This leads to data cleaning being deprioritized at many sites with data query volumes increasing as a result.   The second challenge is that sites do not have effective data visualization tools to facilitate the review of large quantities of patient data. Most EDC or e-source platforms present the data one module at a time so the reviewer can only see a limited slice of data at any given point. They are set up for data entry, but not data review. In addition, the data is often captured in multiple systems, so cross-referencing data adds to the complexity of the review. Sponsors and CROs have medical and central data review teams that combine data across unique data sets and present the data over time so that a data reviewer can easily see inconsistent data… Furthermore, in many of these systems, they are now presenting the data using statistical signals so that outlier data can be flagged for the end user to review. Does it really make sense that the secondary reviewers of data have better tools than the primary reviewers of clinical data? There is a potential solution to this problem; sponsors could deploy centralized Data Operation Specialists (DOS) to remove the burden of data review and cleaning from the clinical trial site. This concept has already been deployed as a result of the pandemic when sites fell behind in data collection and cleaning activities. If this solution works well for an urgent situation, why not consider this a more permanent strategy that is deployed proactively?  Consider a reality where each site had a DOS that partnered with them to clean and process all of their clinical trial data with the best available data visualization software. Imagine a world where the site actually gets support to clean the sponsor’s clinical data, and the data gets captured and cleaned in real-time, thus avoiding a huge source of stress between sponsors and their clinical trial sites.  

By Liz Corcoran, Director, Research Strategy, Teckro and Jenn Weinberg, Director of Oncology, Teckro Advances in clinical development continue to drive efficiencies in the numerous and arduous processes involved in executing clinical trials. The changing technological landscape presents many opportunities to streamline further and capitalize on the ability of clinical trial practitioners to do more and do it faster and with greater accuracy. Even with this evolution, timelines are extending, staffing issues are mounting, protocols are becoming more complex, access to patients is more difficult, and costs are rising. As such, many patients still face long waiting periods for potentially lifesaving treatments.  A growth in resignations is leading to a shortage of qualified, experienced staff to conduct and monitor clinical research, resulting in further issues including lengthy onboarding periods. New clinical research staff are often not only new to clinical research itself but may not have the in-depth knowledge of a specific therapeutic area, which adds to the learning curve.   Difficulty filling open site and clinical research associate (CRA) positions is driving a subsequent delay in opening new studies, often leading to delayed or lower enrollment. Studies starting with no assigned clinical research coordinator (CRC) are becoming more common. The rising pressure on clinical trial teams means less time spent on research, less time with patients, and more effort to deal with the administrative, regulatory, and training deliverables. Experienced CRAs and Study Coordinators Are Resigning in Large Numbers   This burden is carried heavily by CRAs as well as sites. Between Q1 2021 and Q1 2022, the highest number of resignations was among those aged 40-60 with more than 10 years of experience. In previous years, employees in less tenured groups led in overall resignation rates. Between 2020 and 2021, that changed. The current resignation rate of employees with a 5-10 year tenure is 60% higher than in 2020. For employees with a 10-15 year tenure, it was 55% higher in 2021 than in the same period of 2020 (Source: Research & Insights Group Visier Inc 2021).   CRAs and CRCs play a pivotal role in clinical research management and execution. Sponsors rely heavily on both. Yet, while the roles are vital, the jobs are complex, arduous, and demanding. They face long, busy hours to complete time-intensive activities. CRAs are often overburdened and under-resourced. They must use multiple systems, technologies, and communication tools across the clinical trial lifecycle – all of which differ by the sponsor.   Many sites are asking sponsors for help to manage the issue of time and staffing, both to fill the resource shortage and to assist current staff with particularly time-consuming tasks such as data entry, regulatory and filing requirements. However, employing temporary workers is driving unexpected increases in the study’s budget as sponsors are financially responsible for the extra headcount. Hiring less experienced staff also requires further training and site oversight.   Helping Sites and CRAs Work Smarter    The clinical research industry needs to change the current way of working, to be smarter and more efficient with clinical staff time and the activities they are expected to complete. Using technology to smartly drive efficiency and really listening to sites’ requirements will help alleviate problems such as resource shortages. There should also be consideration given to what tasks can be executed remotely vs. onsite to positively impact CRA and site bandwidth. CRA time can be leveraged in more meaningful ways, such as improving site and patient experience.   Sponsors are also being creative in looking for solutions to their resource constraints, but not all make them a better or more attractive partner to sites:   Outsourcing different tasks to other countries has time zone implications and adds additional study team members who will contact sites for various reasons   Large and complex study start up teams can result in sites not knowing who to contact with questions or follow-up information   Outsourcing more roles to a CRO, who is also feeling the pain of increased resignations, can mean multiple turnovers in monitors throughout the course of a trial   Numerous vendors increase the “noise” and make it more difficult to complete tasks in the most efficient way possible    The increasing number of stakeholders is causing confusion at sites because they are often unsure who to contact. This is causing delays in response and turnaround time to complete tasks. Unfortunately, turnover at sites, CROs and sponsors is negatively impacting study timelines, budget, and ultimately quality.  Reducing CRA and Site Burden The continuous turnover of site staff and CRAs coupled with the need to do more with less, increases the importance of completing tasks in a timely, efficient manner. Everyone should have confidence that they are using the most current protocol and study reference material, all the while ensuring they have quick access to the correct tools and contacts. Let’s remember, looking for documents for more than a minute is longer than clinical trial staff have to spare! By streamlining communication, sites get their questions answered quickly. Monitors spend less time fielding site queries, reducing the cyclical rounds of communication. With Teckro, CRAs can monitor site engagement remotely and plan site visits effectively by sending important study updates, revising and refreshing documentation, and reducing the dependency on arduous paper trails – all while in transit. At Teckro we’ve built a clinical trial hub that delivers efficiency for site staff, monitors and CRAs with a unique integrated solution that helps relieve the burden of clinical trial monitoring, through simplified site communication and site management. Teckro links trial stakeholders to one another, to vital study content, and to meaningful trial data – all at the point of care. Ultimately, sites and CRAs need to learn to work together in new, smarter ways, to ensure that patient safety is maintained, and study quality is not compromised. As with any other successful relationship, transparency and good communication are key.     Giving CRA time back: learn how 

What does the clinical research workforce look like right now?  It’s no secret that the workforce shortage in clinical research is a significant industry issue. Nicole Mills, SCRS Education and Knowledge Management Lead shared that according to CareerBuilder, there are currently 6.6 million clinical research jobs posted in the U.S., yet only 5.7 million available hires, which means almost one million more jobs are available than talent available nationwide. The issue is exacerbated when companies need specific skill sets or experience levels.  For every 1 clinical research coordinator (CRC) looking for a job, there are 7 jobs posted. For nurses, it’s a 1 to 10 ratio. For regulatory affairs, it’s 1 in 35. These numbers can vary drastically by city or state as well. For example, when looking at data for California, there are 5,000 clinical research jobs but only 1,400 clinical research professionals looking for jobs.  As of July 2022, there were 62,000 new job postings for clinical research roles and 17,000 of them were “unique” – meaning they didn’t fit a traditional clinical research coordinator-type role. Companies are diversifying traditional roles of coordinators while adding more roles such as home health nurses, IT compliance, regulatory data management, and other positions for adapting to new technologies and protocols.  Bridging the gap  Sites are having to get creative when it comes to hiring, whether that be salary negotiations or offering additional incentives such as hybrid scheduling or remote work. Additionally, sites in certain cities where the cost of living is higher are having to offer increased salaries to recruit new staff. These same sites are often competing with CROs and Sponsors that have higher budgets for salaries and sign-on bonuses, which can make recruiting especially challenging. Out of the 2,400 open positions that listed salaries, $82,000 was the median salary for a clinical research coordinator, with the range anywhere from $40,000 up to $120,000. David Vulcano, SCRS Honorary President and Vice President of Research Compliance and Integrity at HCA Healthcare shared that compensation has increased approximately 40-60% from pre-pandemic levels, which not only includes salaries but also retention bonuses and other benefits.  Not all sites can meet the salary and benefit options that other organizations may offer, which contributes to high turnover among site staff. SCRS gathered anecdotal data regarding site staff retention and found the turnover rate has increased 2-3x from pre-pandemic levels. When study coordinators leave, it can take 6-12 months for sites to get back on track with that study.  SCRS and industry partners have discussed offering a study continuity plan to help minimize the impact to the site and study when coordinators are recruited by a Sponsor or CRO. The continuity plan would be offered by the Sponsor or CRO if that organization recruits a coordinator from the site.  Many organizations are having to adjust expectations for the roles they need. They may hire someone without clinical research experience but with therapeutic area experience or vice versa. Looking for transferrable skills from a general healthcare background or other industries is also becoming more prevalent. Candidates with experience in project management, administrative, or technology-related roles are helping bridge the gap. However, those hires typically require additional training on all the aspects of clinical research, which some sites may not have the time to manage.  Taking action  How do we alleviate some of the training issues for sites and make it easier to hire people who have less experience, or that come from other industries? SCRS created a Workforce Task Force with a site toolkit to help address this issue. The toolkit shares solutions for sites to train more efficiently, retain current staff, manage budgets and cash flow, and what additional benefits to consider such as childcare, more flexible schedules, work-from-home days, transportation options and employee recognition programs.   Ultimately, we need new avenues into our industry. Awareness of clinical research is at an all-time high due to the clinical studies involving COVID-19 vaccines and this can be used to encourage more people to enter clinical research. Working with nurse education centers and universities is underway for several industry organizations already.  The workforce will continue to be a hot topic of discussion as we look for more solutions to address current challenges. Watch the Sites NOW discussion recording here and join us for the next Sites NOW meeting to be a part of the conversation!