Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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2 Defining the Vision
2 Defining the Vision
Pages 5-18
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(King) • Digital health technologies can enable research to be conducted at the scale needed for studies to be representative, reliable, and adequately powered to produce meaningful data.
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ENVISIONING A MORE PERSON-CENTERED AND INCLUSIVE CLINICAL TRIALS ENTERPRISE A Perspective on Person-Centeredness and Inclusivity: Moving Forward Together King's community has experienced high rates of COVID-19 cases during the pandemic. He described his work participating in focus groups for Johns Hopkins University and the Robert Wood Johnson Foundation, and arranging for conversations between several pharmaceutical companies and his congregation to discuss vaccination and to address issues with misinformation.
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King said the clinical trials enterprise is using "the wrong message and the wrong messengers" when trying to engage minority populations in clinical trials. What is needed, he continued, is a person-centered model of community-based participatory research that reaches African Americans in the spaces where they gather to share their faith and their fears and where trusted relationships are built.
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Breakout discussants observed that only a small subset of the general population participates in clinical trials, which compounds the challenges of enrolling a diverse and representative trial population. Participants discussed how elements of study design could create barriers to participation for minorities (e.g., inclusion and exclusion criteria, convenience of site locations, or appointment hours)
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. He suggested that the clinical trials enterprise embrace the coming digital disruption and adapt technologies to improve clinical research and care.
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A fourth approach Califf suggested was to involve patients and participants directly in research. Digital health technologies can enable direct interaction with patients and potential trial participants to gain input on their priorities, preferences, and concerns (e.g., features of trial design and outcomes of importance to patients)
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; and how to balance the risks versus the benefits of clinical trial participation. Ultimately, he said, "Digital technology can either be a rising tide that raises all boats if we make it equitable … or it can be used much like it is now in most of our health systems … to segment populations to optimize the situation for some people, particularly those who are already digitally enabled." Using Technology to Optimize the Clinical Trials Enterprise: Breakout Discussion Highlights A summary of the points made by individual breakout group participants was provided in plenary session by Celia Witten of the Center for Biologics Evaluation and Research (CBER)
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The Use of Digital Health Technologies in Trials Breakout participants discussed the need to intentionally consider whether the use of digital health technologies in clinical trials would be deployed as a tool to more effectively mine data from communities (i.e., with limited return of information or benefit to the community) versus being used as a tool to work more collaboratively with patients and communities (e.g., to reduce the burden of trial participation and return information back to individuals and communities, and to build value and transparency in the research enterprise)
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Participants discussed the importance of responsibly and transparently sharing data from clinical trials with communities to build public trust in clinical research and add value back to the community. ENVISIONING A MORE RESILIENT, SUSTAINABLE, AND TRANSPARENT CLINICAL TRIALS ENTERPRISE A Perspective on the State of Clinical Trials in 2021 The clinical research enterprise primarily serves the needs of three key stakeholder groups: sponsors, patients, and societies, Levy said.3 Clinical research is conducted by the industry sponsors, who seek to improve the speed, efficiency, and success rates of their trials.
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Looking beyond operational efficiencies, Levy suggested that the expanding use of data and technology in trial design and execution will significantly improve the speed, efficiency, and success of clinical trials in the coming decade. Real-world data collected in health care settings can help provide a more complete picture of local patient characteristics and standards of care, which can be used to refine eligibility criteria and site selection, making trial enrollment more efficient and predictable.
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• Advances in genomics and proteomics will allow for tailoring of treatments to individual patient needs and increase the probability of patient benefit. "All these changes, which are made in the interest of patients, will benefit sponsors by improving recruitment, retention, and data quality," FIGURE 2-1 One sponsor's qualitative impression of the adoption and impact of remote approaches on the conduct of clinical trials during a pandemic.
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Societal Perspective Levy observed that not enough clinical trial data are available on minority populations because of the underrepresentation of minority participants in clinical trials. He noted that participating in clinical trials "is a problem with deep historical roots" for many African Americans, and added that limited access to clinical trials in general compounds the barriers to participation for many underrepresented populations.
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A more patient- and society-focused clinical research enterprise can also be more efficient and productive for industry trial sponsors. Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise: Breakout Discussion Highlights A summary of the points made by individual breakout group participants was provided in plenary session by Clay Johnston of the Dell Medical School, Peyton Howell of Parexel, Jeanne Regnante of the LUNGevity Foundation, and Celia Witten of CBER at FDA on behalf of each of the four breakout groups.
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Breakout discussants suggested there may be lessons learned based on the UK RECOVERY Trial (see Chapter 5) and other ongoing efforts that have successfully coordinated clinical trials and enabled the sharing of standardized trial data.
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