This virtual, 4-part public workshop provided a venue for stakeholders to consider a transformed clinical trials enterprise for 2030. Workshop participants considered lessons learned from progress and setbacks over the past 10 years, since the previous workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States, and, looking forward, discussed goals and key priorities for advancing a clinical trials enterprise that is more efficient, effective, patient-centered, and integrated into the health delivery system of 2030. The workshop was hosted by the National Academies Forum on Drug Discovery, Development, and Translation.
- Part One (January 26, 2021) provided an overview discussion on how an envisioned 2030 clinical trials enterprise may differ from the current system. It discussed key challenges and opportunities in improving person-centeredness and inclusivity, building resilience and transparency, and integrating new technologies. Each subsequent part of the workshop considered changes in the clinical trials enterprise made in response to COVID-19 that may have established positive and sustainable examples for the future, and considered specific action steps that individual stakeholders could take to support an envisioned change from 2020 to 2030.
- Part Two (February 9, 2021) considered achievable goals to enhance person-centeredness and inclusivity in the clinical trials enterprise; and discussed ways to improve public engagement and partnership.
- Part Three (March 24, 2021) considered approaches to build resilience, sustainability, and transparency. The discussion included the convergence and integration of clinical research and clinical practice; data sharing and management; and efficient, engaging scientific communication.
- Part Four (May 11, 2021) considered ways the thoughtful and deliberate use of new technologies could improve the clinical trials enterprise and support goals outlined in prior workshop parts.
Below are materials for each part of the workshop, including background information, the planning committee, and agenda and briefing book.
For additional information on this workshop, please visit our project page.
Background
Clinical trials research has changed dramatically over the last decade. The biological, physical, and digital spheres are merging; clinical research and health care are at a critical juncture; new approaches enable the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are changing possibilities for the conduct of clinical research. These opportunities hold great promise for advancing our understanding of health maintenance and prevention, disease progression, and developing new therapies for patients. At the same time, the clinical research enterprise is strained by rising costs, an evolving regulatory and economic landscape, increasing clinical trial complexity, difficulties in the recruitment and retention of research participants, and a clinical research workforce that is under tremendous stress. Some, but not all, of these challenges and opportunities were predicted in the 2011 National Academies workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020. There is now a need for stakeholders from across the clinical research lifecycle to consider lessons learned from progress and setbacks over the past 10 years and broadly consider goals and key priorities for advancing a clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health delivery system of 2030.
A planning committee of the National Academies of Sciences, Engineering, and Medicine planned and conducted a virtual, 4-part public workshop designed to consider a transformed clinical trial enterprise for 2030, featuring invited presentations and discussions on:
- Lessons learned from progress and setbacks over the past 10 years.
- How an envisioned 2030 clinical trials enterprise might differ from the current system.
- Key priority challenges and opportunities when it comes to the 2030 clinical trials enterprise.
- The following core themes in framing a 2030 agenda:
- Diversity and inclusion of clinical trial participants
- Convergence of clinical research and clinical practice
- Clinical trial data sharing
- Incorporation of new technologies into drug research and development
- Workforce and career development
- Public engagement and partnership
- Regulatory Environment
- Cultural and Financial Incentives
- Practical short- and long-term goals for improving the efficiency, effectiveness, person-centeredness, inclusivity, and integration with healthcare of the clinical trials enterprise.
Planning Committee
Steven Galson (Co-Chair), Amgen
Esther Krofah (Co-Chair), FasterCures, Milken Institute
Amy Abernethy, Office of the Commissioner, FDA
Anita LaFrance Allen, University of Pennsylvania
Christopher P. Austin, National Center for Advancing Translational Sciences, NIH
Howard A. Burris III, Sarah Cannon
Luther T. Clark, Merck & Co., Inc.
Giselle Corbie-Smith, The University of North Carolina at Chapel Hill
M. Khair ElZarrad, Center for Drug Evaluation and Research, FDA
Jennifer Goldsack, Digital Medicine Society
Richard A. Moscicki, PhRMA
Amy Patterson, National Heart, Lung, and Blood Institute, NIH
Joseph Scheeren, Critical Path Institute
Anantha Shekhar, University of Pittsburgh
Pamela Tenaerts, Medable
Christopher Yoo, Systems Oncology
Meeting Materials
Below are materials for the workshop, including an agenda, briefing book, and presentations.
For additional information on the workshop, including the planning committee and sponsors, please visit our project page.
The blog posts associated with the Envisioning a Transformed Clinical Trials Enterprise for 2030 virtual workshop are listed below and can be found at https://www.healthaffairs.org/topic/ss170.
Building A Resilient, Sustainable, And Representative Clinical Trials Enterprise. Carolyn Shore, Gregory Simon, and Ann Taylor highlight critical components necessary to achieve the envisioned clinical trials enterprise in 2030.
Clinical Trials in Crisis: Building on COVID-19’s Lessons Toward a Better Future. Esther Krofah, Steven Galson, Robert Califf, and Gregory Simon synthesize three central categories emerging from these workshop discussions for future improvement—engagement, efficiency, and coordination—and issue a call to action.
A Future of Trusted Clinical Trials: Communication Strategies to Encourage Trust and Transparency. Brian Southwell discusses the importance of fostering trust and transparency in the clinical trials enterprise for improving the person-centeredness and relevance of clinical trial research.
The Future of Clinical Trials: How Will New Technologies Affect the Lives of Participants? Andy Coravos, Eric Perakslis, and Sam Roosz envision how the lives of four fictional individuals could be changed with the integration of technologies into the clinical trials enterprise.
Driving Towards More Inclusive Clinical Trials by 2030: Action Without Strategy Is Aimless, Strategy Without Action Is Powerless. Silas Buchanan lays out a vision for a clinical trials enterprise that benefits from diversity in its participants and workforce through ongoing community engagement.
Transforming Clinical Trials: A New Vision for 2030. Marilyn Metcalf and Rob Weker lay out their vision for person-centered clinical trials in the year 2030 and provide an outline of how to get there.
Pamela Tenaerts, Clinical Trials Transformation Initiative
Christopher Yoo, Systems Oncology