Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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5 Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
5 Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
Pages 49-68
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• For the clinical trials enterprise to be sustainable, it has to be worthwhile and practical for frontline health care providers who care for underrepresented populations to participate as investigators. (Ofili)
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Trial as an example to highlight the importance of conducting randomized clinical trials and demonstrate how clinical trials can be a core component of clinical care. Three panelists then shared their frontline experience addressing some of the challenges facing the clinical trials enterprise.
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. Landray referred workshop participants to a recent publication in which he describes how smart trial design and streamlined operations, integrated data and technology, and flexible regulatory approaches can lead to improved patient care and public health (Collins et al., 2020)
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Leveraging existing information reduces workload for the trialists and facilitates long-term follow-up, Landray explained. He noted that, although NHS is the primary provider of health care in the United Kingdom, data are collected in many different databases as NHS spans 4 nations, nearly 200 acute hospital organizations, and 10,000 primary care practices.
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In closing, Landray reiterated that trials need to be feasible for trial participants and staff, inclusive, and focused on outcomes of importance to patients. Transforming to a system in which trials are part of care BOX 5-1 Lessons from RECOVERY Martin Landray, professor of medicine and epidemiology at the Nuffield Depart ment of Population Health at the University of Oxford, highlighted six key elements of success for the RECOVERY trials in the United Kingdom that could be applied to clinical trials in the United States.
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Ofili also highlighted the need for metrics to track progress as new provider groups become part of the clinical trials enterprise. Engaging Patients in the Trial Process to Drive Sustainability As an investigator and a two-time breast cancer survivor, SegarraVázquez has experience on both sides of clinical trials, and she said that sustainability of the enterprise requires informing the public about t rials,
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Envisioning and Achieving a Collaborative, Community-Based Clinical Research Infrastructure Lewis-Hall observed that there is no master plan for transforming the clinical trials enterprise. Instead there are many different plans, and many people working "with great passion" who are making an impact, but there is no central action plan in which everyone can participate.
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It is deeply embedded in an academic culture that has long rewarded individual ingenuity over the type of collaboration needed for the clinical trials enterprise envisioned for the future. Ofili suggested that individual and institutional curiosity-driven research and collaborative, community-based research do not need to be mutually exclusive.
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Southwell described how a transformed clinical trials enterprise for 2030 might look. • "Trials are advancing science by enrolling people who are the most directly impacted by and most directly burdened by diseases." • Trial enrollment is at sufficient levels and people are less hesitant to participate.
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Research has shown, however, that simply making information (e.g., study results) available may not on its own guarantee public understanding, Southwell said.6 Understanding 5 Southwell referred participants to a blog post he authored for the ABIM Foundation titled Trust as an Antidote to the Viral Spread of Medical Misinformation, available at https:// medium.com/@briansouthwell_94233/trust-as-an-antidote-to-the-viral-spread-of-medicalmisinformation-12b0f2d3905a (accessed April 13, 2022)
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Facilitating the Cultural Change Needed to Improve Trial Diversity Envisioning the clinical trials enterprise for 2030, Bryson anticipated changes with regard to decentralizing clinical trials, the use of technology, and diversity in clinical trials. She focused her remarks on some of the changes needed to improve diversity in clinical trials, noting that decentralizing clinical trials can help to improve recruitment of diverse populations, and the use of technology for ongoing communication with trial participants can promote retention for existing trials and formation of positive long-term relationships that provide value to participants and potentially influence their decision to participate in future trials.
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For example, Bryson explained, Lucy might consult five people directly about her decision, each of whom is influenced by other people in their own networks, and so on. This indicates that taking opportunities to raise awareness about participating in clinical trials among the people in Lucy's networks can ultimately influence Lucy's decision on whether she will choose to participate.
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Creating Solutions That Promote Trust Tenaerts described the approach taken by CTTI to promote a more sustainable and resilient clinical trials enterprise. CTTI aims to create structure and frameworks to support change, she said.
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CTTI then develops tools and recommendations to promote change and new norms. In the case of clinical trials, for example, a new norm would be including the patient voice from the beginning of the trial process.
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To help enable change, CTTI launched Building Better Clinical Trials: A Case Study Exchange, a database through which organizations can learn how others have implemented CTTI recommendations and tools.11 The exchange has case s tudies from more than 30 organizations that are willing to share how they have used CTTI resources to improve clinical trial efficiency. Short-Term Goals to Ensure a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise: Panel and Breakout Discussion Highlights Following the panel discussion, online participants were divided into virtual Zoom breakout rooms to consider short-term, tangible, measurable goals and actions to ensure a more resilient, sustainable, and transparent clinical trials enterprise, and to discuss relevant technologies, tools, techniques, and models that could be used to support this transformation.
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academic culture as it relates to the clinical trials enterprise continued in the breakout groups. As relayed by Austin, participants emphasized the need for change in the academic system for appointments, promotions, and tenure so that participation by academic research faculty in collaborative clinical studies and team-based research is recognized and rewarded.
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She observed that many community health centers are not formally linked to an academic health center and said HRSA and CMS should also be included in discussions of the clinical trials enterprise. Long-Term Goals to Ensure a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise: Panel and Breakout Discussion Highlights In this breakout session, groups considered longer-term, tangible, measurable goals and actions to ensure a more resilient, sustainable, transparent clinical trials enterprise, and discussed relevant technologies, tools, techniques, and models that could be used to support this transformation.
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Participants dis cussed leveraging existing relationships and building on shared values to establish trust of the clinical trials enterprise within the community. Galson added that the tools for creating more trans parency exist, and highlighted workshop participants' calls for prioritizing it.
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Participants discussed a role for the National Academies in convening stakeholders from across the clinical trials ecosystem to develop a national action plan.
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