This virtual, 4-part public workshop will provide a venue for stakeholders to consider a transformed clinical trial enterprise for 2030. Workshop participants will consider 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, discuss 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 will be hosted by the National Academies Forum on Drug Discovery, Development, and Translation.
This virtual workshop will be conducted through four parts:
- Part One (January 26, 2021) will provide an overview discussion on how an envisioned 2030 clinical trials enterprise may differ from the current system. It will discuss key challenges and opportunities in improving person-centeredness and inclusivity, building resilience and transparency, and integrating new technologies. Each subsequent part of the workshop will consider changes in the clinical trials enterprise made in response to COVID-19 that may establish positive and sustainable examples for the future, and consider specific action steps that individual stakeholders could take to support an envisioned change from 2020 to 2030.
- Part Two (February 9, 2021) will consider achievable goals to enhance person-centeredness and inclusivity in the clinical trials enterprise; and discuss ways to improve public engagement and partnership.
- Part Three (March 24, 2021) will consider approaches to build resilience, sustainability, and transparency. The discussion will include the convergence and integration of clinical research and clinical practice; data sharing and management; and efficient, engaging scientific communication.
- Part Four (May 11, 2021) will consider ways the thoughtful and deliberate use of new technologies could improve the clinical trials enterprise and support goals outline in prior webinar sessions.
Below are materials for each part of the workshop, including background information, the planning committee, and agenda and briefing book (when available).
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 will plan and conduct 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, Clinical Trials Transformation Initiative
Christopher Yoo, Systems Oncology