Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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6 Opportunities for Transformation
6 Opportunities for Transformation
Pages 69-78
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From page 69... ...
(Abernethy) • In a public health emergency, the goal of the clinical trials enterprise should be to rapidly generate robust, actionable data that can be used to improve standards of care and dis ease outcomes.
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Over the course of the workshop, current and former FDA officials shared their personal perspectives on the current state of the clinical t rials enterprise; the unique opportunity to learn from how product development unfolded during the COVID-19 pandemic response; and how to realize the vision of a more efficient, effective, person-centered, and inclusive clinical trials enterprise that is integrated with routine health care delivery.1 OPPORTUNITIES TO TRANSFORM THE CLINICAL TRIALS ENTERPRISE Mark McClellan, director of the Duke–Margolis Center for Health Policy and former FDA commissioner and former CMS administrator, shared his perspective on opportunities to transform the clinical trials enterprise in a conversation moderated by Amy Abernethy. Creating More Person-Centered and Accessible Clinical Trials "There is … broad awareness that we ought to be able to do better," McClellan said, referring to creating a more person-centered and easily accessible clinical trials enterprise.
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Abernethy summarized that clinical trials conducted within the context of clinical care should still provide robust answers to key questions and keep patients safe, all while increasing efficiency overall. Building Trust and Engaging Communities Building community trust in the research enterprise and including the patient perspective in the early stages of trial development are "hallmarks" of clinical trials that have been successfully inclusive of diverse populations, McClellan said.
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He added that there are opportunities to facilitate change in the clinical trials enterprise by building on ongoing public health policy activities. For example, the 5 For more information, see https://ctti-clinicaltrials.org/who_we_are/transforming trials-2030 (accessed April 13, 2022)
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He noted that the federal government is interested in policy changes that support the collection of better postmarket data and the translation of that data into health care practice. For example, CMS called for public comment on a new M edicare coverage pathway, Medicare Coverage of Innovative Technology,6 for FDAdesignated breakthrough medical devices, and he anticipated this may inform development of new policies related to federal support for registries or other platforms for collecting evidence after marketing approval.
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Abernethy emphasized that the technology industry should be included in stakeholder discussions as partners, rather than simply as vendors providing services. Technology partners can help envision how the clinical trials enterprise can evolve for the future in terms of technical and data capabilities, she said.
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TAKING THE LESSONS FROM THE COVID-19 PANDEMIC RESPONSE FORWARD Janet Woodcock, acting commissioner of food and drugs, FDA shared her perspective on the current status of the clinical trials ecosystem, discussing the response to the COVID-19 pandemic as a case example, and suggested key actions for moving forward. Studying the COVID-19 Pandemic Response as a Model In a public health emergency, such as the COVID-19 pandemic, the goal of the clinical trials enterprise should be to rapidly generate robust, actionable data that can be used to improve standards of care and disease outcomes, Woodcock said.
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Woodcock said that conducting clinical research primarily at academic medical centers results in competition for patients, study staff, and other resources, which can slow study progress and limit evidence generation. At the same time, many of those who have the disease being studied receive their health care in other settings and are not afforded the opportunity to participate in, and possibly benefit from, a clinical study.
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From page 77... ...
government is undertaking efforts to learn from the experiences of COVID-19 clinical trials, and there are lessons to be learned and leads to follow from the CTTI vision for clinical trials in 2030 and the efforts of the TransCelerate biopharmaceutical member companies. Galson said a silver lining in the pandemic response is the ability to learn from "the real-life examples of the problems with our chronic lack of inclusiveness, and our challenges with bringing people together in a way that creates data that are actually useful for the health care system." He urged participants to take advantage of the momentum and apply these lessons now to transform the clinical trials enterprise for the coming decade.
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