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3 Enhancing Outcomes in a More Person-Centered and Inclusive Clinical Trials Enterprise
Pages 19-34

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From page 19...
... • Stakeholders across the clinical trials enterprise need to better explain the usefulness and value of clinical research for the practice of medicine and clinical care. (Anderson)
From page 20...
... , which directed the agency to study the participation and analysis of demographic subgroups in clinical trials and to create a plan to support inclusive clinical trials.1 One product of FDASIA was the FDA Center for Drug Evaluation and Research's Drug Trials Snapshots program. Araojo shared some specific findings from a recent Snapshots report summarizing participant demographics in clinical trials of new products from 1 See https://www.fda.gov/regulatory-information/food-and-drug-administration-safety and-innovation-act-fdasia/fdasia-section-907-inclusion-demographic-subgroups-clinical-trials (accessed July 1, 2021)
From page 21...
... research, outreach, and communication that works toward addressing health disparities," Araojo said.3 Activities within the agency's current authorities include, for example, supporting intramural and extramural research; implementing culturally and linguistically appropriate strategies, tools, programs, initiatives, and campaigns; and issuing guidance documents. Improving diversity in clinical trials is a key priority for FDA, and Araojo referred participants to a recently released guidance for industry, Enhancing the Diversity of Clinical Trial Populations -- Eligibility Criteria, Enrollment Practices, and Trial Designs.4 The guidance addresses methods to improve trial recruitment so those enrolled reflect those who will ultimately use the product being studied.
From page 22...
... Protocols or consent forms that are not acceptable or understandable to patients can be a barrier to recruiting a diverse population, and experience has shown that community engagement is an effective method for developing longterm connections with diverse populations. Araojo highlighted the need for engaging patient advocacy groups to learn how to make trials less burdensome with regard to trial design, logistics, recruitment, and retention; engaging cultural ambassadors, faith-based organizations, and trusted leaders in the community; and eliminating language barriers.
From page 23...
... Krofah asked panelists to comment on the concerns that including patients in discussions of trial design and working to increase diverse participation slows the process and adds expense. O'Boyle said that ­failure to recruit or retain trial participants slows the process and increases expense.
From page 24...
... The session was moder ated by Luther Clark, deputy chief patient officer and global director for scientific, medical, and patient perspective at Merck & Co. Forging Equitable Partnerships with Community-Based Organizations8 "A more inclusive clinical trials enterprise in 2030 will largely be defined by the number of equitable partnerships … created with underserved, faith, and community-based organizations," Buchanan began.
From page 25...
... , conversations about health also take place at barbershops and beauty salons, which are trusted community institutions where people feel safe discussing their personal concerns. Buchanan observed that the clinical trials enterprise has long underestimated the importance of equitably partnering with these trusted organizations as emissaries to the community.
From page 26...
... . The Institute for eHealth Equity is also launching Our Healthy Community teams, a social network for community-based organizations designed to "shorten the distance" between the community and the clinical trials enterprise, health care providers, payers, and other stake­holders in health.
From page 27...
... The translation of research into clinical practice can be supported by prioritizing patient involvement in drug R&D and regulatory decision making when it comes to early disease detection, disease management, and treatment, Metcalf said. Metcalf referred participants to a prior workshop of the National Academies' Forum on Drug Discovery, Development, and Translation on Advancing the Science of Patient Input in Medical Product Research and Development11 (NASEM, 2018)
From page 28...
... Understanding the past is necessary to develop the solutions needed for the future, and Anderson described several examples of movements that changed policy and practice in health care. In the late 1980s, during the early days of the HIV/AIDS epidemic, activists took an "outside/ inside" approach to effecting change by staging large public demonstrations outside that demanded attention from government, while also working with science and policy experts to propose specific policy changes from inside organizations.
From page 29...
... • Developing a pipeline of diverse scientists, clinical researchers, and health care providers. Short-Term Goals to Foster a More Person-Centered and Inclusive Clinical Trials Enterprise: Panel and Breakout Discussion Highlights Following the panel discussion, workshop participants were divided into virtual Zoom breakout rooms to consider short-term, tangible, and measurable goals and actions that could help ensure a more person-­ centered and inclusive clinical trials enterprise, and to discuss technologies, tools, and techniques that could be used to enhance inclusiveness and equity in clinical trials.
From page 30...
... ­Barbara Bierer, director of the Multi-Regional Clinical Trials C ­ enter of Brigham and Women's Hospital and Harvard University, said that information on social determinants of health is needed to inform diverse trial enrollment efforts, and that good, quick indi cators of social determinants of health are needed for use in data collection (versus extensive, often uncomfortable, questioning of patients)
From page 31...
... • Moving the clinical trials enterprise into health care settings. Breakout participants discussed the importance of developing robust clinical trial networks within communities, and investing in community-based trial infrastructure for the long term.
From page 32...
... • Identifying the problems that could be solved with technology. Breakout participants discussed how technology could help over come many of the barriers to more person-centered and inclusive clinical trials, Clark reported.
From page 33...
... The clinical trials enterprise needs to move beyond "islands of excellence" to "a whole ecosystem of excellence for all people," she said. • How to effect change was a topic across breakout group discussions, including the roles of mandates and enforcement, incentives, invest ments and capacity building, accountability, and the will to make change.


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