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Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Appendix C

Workshop Agendas

Envisioning a Transformed Clinical Trials Enterprise for 2030: A Virtual Workshop
January 26, February 9, March 24, and May 11, 2021

Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Workshop Part 1: January 26, 2021
11:00 a.m.–3:30 p.m. ET

11:00 a.m. Welcome and Opening Remarks
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Global Regulatory Affairs and Safety
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute

SESSION I
A MORE PERSON-CENTERED AND INCLUSIVE CLINICAL TRIALS ENTERPRISE

Session Objective:

  • Discuss key priority challenges and opportunities when it comes to person-centeredness and inclusivity in the 2030 clinical trials enterprise
11:10 a.m. A Story in Action: Person-Centeredness and Inclusivity
TERRIS KING
Former Director, Office of Minority Health
Centers for Medicare & Medicaid Services
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
11:25 a.m. Facilitated Breakout Groups (30 min)
Discussion Questions:
  • Do you agree with the proposed goals listed below for enhancing person-centeredness and inclusivity?
  • What would you change, and how?
  • What are potential interim actions or milestones that might be key to achieving these goals?
Goals to Consider for Enhancing Person-Centeredness and Inclusivity
  • Improve representation and relevance
  • Improve community engagement, transparency, and “user-friendliness” to foster trust, counter misinformation, and meet the needs of patients
  • Demonstrate trustworthiness to the general public of clinical trials
  • Engage and prepare a diverse clinical research workforce
11:55 a.m. Breakout Group Report-Outs (10 min)
12:10 p.m. BREAK (30 min)

SESSION II
A MORE RESILIENT, SUSTAINABLE, AND TRANSPARENT CLINICAL TRIALS ENTERPRISE

Session Objective:

  • Discuss key priority challenges and opportunities when it comes to building a more resilient, sustainable, and transparent clinical trials enterprise
12:45 p.m. The State of Clinical Trials in 2021: A Perspective from Industry
ELLIOTT LEVY
Senior Vice President, R&D Strategy and Operations
Amgen Inc.
1:00 p.m. A Story in Action: Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
JANET WOODCOCK
Acting Commissioner of Food and Drugs
U.S. Food and Drug Administration
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
1:15 p.m. Facilitated Breakout Groups (30 min)
Discussion Questions:
  • Do you agree with the straw vision statement for building a more resilient, sustainable, and transparent clinical trials enterprise (below)?
  • What would you change, and how?
  • What are some potential interim actions or milestones that might be key to achieving these goals?
Goals to Consider for Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
  • Improve community engagement, transparency, and “user-friendliness” to foster trust, counter misinformation, and meet the needs of patients
  • Reduce complexity and streamline trials and trial start-up, and standardize key data elements
  • Support regulatory robustness, flexibility, and built-in ability to adjust (e.g., in times of stress, to handle new tech robustly)
  • Reduce conduction of “uninformative” clinical trials and prioritize resources to robustly designed trials
  • Generate a larger amount of high-quality evidence at lower cost
  • Reduce risk aversion to improve research questions and trial design innovation
  • Embrace novel statistical techniques to power trials
  • Connect and embed clinical care and clinical research
1:45 p.m. Breakout Group Report-Outs (10 min)
2:00 p.m. BREAK (30 min)

SESSION III
MORE APPROPRIATE USE OF TECHNOLOGIES TO OPTIMIZE THE CLINICAL TRIALS ENTERPRISE

Session Objective:

  • Discuss key priority challenges and opportunities when it comes to appropriately using new technologies to optimize the 2030 clinical trials enterprise
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
2:30 p.m. A Story in Action: Optimizing with New Technologies
ROBERT CALIFF
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health
2:45 p.m. Facilitated Breakout Groups (30 min)
Discussion Questions:
  • Do you agree with the proposed goals listed below for more appropriately using new technologies to optimize the clinical trials enterprise?
  • What would you change, and how?
  • What are some potential interim actions or milestones that might be key to achieving these goals?
Goals to Consider for More Appropriately Using Technology to Optimize the Clinical Trials Enterprise
  • Decentralize clinical trials
  • Use digital tools for clinical trials management
  • Develop resources to help institutions that need more support
  • Increase local capacity for research innovation
  • Collate efforts to frame new technologies as part of an ecosystem rather than a series of unrelated one-off tech solutions
  • Develop and deploy systems and tools to combine many sources of data
  • Incorporate patient input into research
  • Advance analytics for recruitment and analysis
3:15 p.m. Breakout Group Report-Outs (10 min)

WRAP-UP

3:30 p.m. Wrap-Up Discussion and Closing Remarks
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Global Regulatory Affairs and Safety
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute
3:35 p.m. ADJOURN
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Workshop Part 2: February 9, 2021
Enhancing Outcomes in a More Person-Centered and Inclusive Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. ET

11:00 a.m. Welcome and Opening Remarks
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute
LUTHER CLARK, Moderator
Deputy Chief Patient Officer and Global Director, Scientific, Medical, and Patient Perspective
Merck & Co., Inc.

SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE

11:10 a.m. Frontline Experience: A Fireside Chat
ESTHER KROFAH, Moderator
Executive Director
FasterCures, Milken Institute
ELISEO PÉREZ-STABLE
Director
National Institute on Minority Health and Health Disparities
National Institutes of Health
RICHARDAE ARAOJO
Associate Commissioner for Minority Health
Director, Office of Minority Health and Health Equity
U.S. Food and Drug Administration
MEGAN O’BOYLE
Principal Investigator
Phelan-McDermid Syndrome Registry
11:45 a.m. Charge to the Breakout Groups
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
11:50 a.m. “Lightning Round” Breakout Discussion Groups (30 min)
  • What are one to two short-term, tangible, and measurable goals to ensure a more person-centered and inclusive clinical trials enterprise that should be met within the next 5 years—by 2025?
  • What technologies, tools, or techniques could be transformational to improving inclusiveness and equity in the clinical trials enterprise over the next 5 years?
12:30 p.m. Session I Wrap-Up (10 min)
12:45 p.m. BREAK (30 min)

SESSION II THE ROAD TO 2030: A CALL TO ACTION

1:15 p.m. “North-Star” Visions of What Is Possible (10 min each)
SILAS BUCHANAN
Chief Executive Officer
Institute for eHealth Equity
MARILYN A. METCALF
Senior Director, Patient Engagement
GlaxoSmithKline
1:40 p.m. Frontline Experience: A Road Already Traveled
MARGARET ANDERSON
Consulting Managing Director, Strategy and Analytics
Deloitte
1:50 p.m. Charge to the Breakout Groups
2:00 p.m. “Lightning Round” Breakout Discussion Groups (30 min)
  • What are one to two long-term, tangible, and measurable goals to ensure a more person-centered and inclusive clinical trials enterprise that should be met within the next 10 years—by 2030?
  • What technologies, tools, or techniques could be transformational to improving inclusiveness and equity in the clinical trials enterprise over the next 10 years?
2:30 p.m. Session II Wrap-Up (10 min)
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

WRAP-UP

2:45 p.m. Wrap-Up Discussion and Closing Remarks
LUTHER CLARK, Moderator
Deputy Chief Patient Officer and Global Director, Scientific, Medical, and Patient Perspective
Merck & Co., Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
3:00 p.m. ADJOURN

Workshop Part 3: March 24, 2021
Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. Eastern Time

11:00 a.m. Welcome and Opening Remarks
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute

SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE

CHRISTOPHER AUSTIN, Moderator
Director
National Center for Translational Sciences
National Institutes of Health
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
11:10 a.m. Keynote Address
MARTIN LANDRAY
Professor of Medicine and Epidemiology
Nuffield Department of Population Health
University of Oxford
11:25 a.m. Frontline Experience: A Panel Discussion
Physician’s perspective on a true “Learning Health Care System”
ELIZABETH OFILI
Contact Principal Investigator
Research Centers at Minority Institutions Coordinating Center
Patient’s perspective on sustainability
BÁRBARA SEGARRA-VÁZQUEZ
Dean
School of Health Professions, Medical Sciences Campus
University of Puerto Rico
Industry perspective on building community-based research infrastructure
FREDA LEWIS-HALL
Retired Senior Medical Advisor
Pfizer Inc.
12:00 p.m. Charge to the Breakout Groups
12:05 p.m. “Lightning Round” Breakout Discussion Groups (40 min)
Discussion Questions:
  • What are one to two short-term, tangible, and measurable goals to ensure a more resilient, sustainable, and transparent clinical trials enterprise that should be met within the next 5 years—by 2025?
  • What technologies, tools, or techniques could be transformational to improving resilience, sustainability, and transparency in the clinical trials enterprise over the next 5 years?
  • What are specific models of sustainability, resilience, or transparency that participants have encountered in the past year that might be informative for the clinical trials enterprise, and could they be scaled (in part or in whole)?
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
12:45 p.m. Breakout Group Wrap-Up
CHRISTOPHER AUSTIN, Moderator
Director
National Center for Translational Sciences
National Institutes of Health
12:55 p.m. BREAK (30 min)

SESSION II
THE ROAD TO 2030: A CALL TO ACTION

KHAIR ELZARRAD, Moderator
Deputy Director
Office of Medical Policy
U.S. Food and Drug Administration
1:30 p.m. “North-Star” Vision of What Is Possible
BRIAN SOUTHWELL
Senior Director, Science in the Public Sphere Program
RTI International
1:45 p.m. Frontline Experience: A Road Already Traveled
DYAN BRYSON
Founder, Patient Engagement Strategist
Inspired Health Strategies
PAMELA TENAERTS
Former Executive Director
Clinical Trials Transformation Initiative
2:10 p.m. Charge to the Breakout Groups
2:15 p.m. “Lightning Round” Breakout Discussion Groups (30 min)
Discussion Questions:
  • What are one to two long-term, tangible, and measurable goals to ensure a more resilient, sustainable, and transparent clinical trials enterprise that should be met within the next 10 years—by 2030?
  • What technologies, tools, or techniques could be transformational to improving resilience, sustainability, and transparency in the clinical trials enterprise over the next 10 years?
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
  • What are specific models of sustainability, resilience, or transparency that participants have encountered in the past year that might be informative for the clinical trials enterprise, and could they be scaled (in part or in whole)?
2:45 p.m. Breakout Group Wrap-Up and Closing Remarks
KHAIR ELZARRAD, Moderator
Deputy Director
Office of Medical Policy
U.S. Food and Drug Administration
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute
3:00 p.m. ADJOURN

Workshop Part 4: May 11, 2021
Practical Applications for Technology to Enhance the Clinical Trials Enterprise
11:00 a.m.–3:00 p.m. ET

11:00 a.m. Welcome and Opening Remarks
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute

SESSION I
THE ROAD TO 2030: AN ATLAS FOR CHANGE

JENNIFER GOLDSACK, Moderator
Executive Director
Digital Medicine Society
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
11:10 a.m. Keynote Address
AMY ABERNETHY
Former Principal Deputy Commissioner of Food and Drugs
U.S. Food and Drug Administration
11:25 a.m. Frontline Experience: A Panel Discussion
A perspective on patient burden and accessibility
TARA HASTINGS
Senior Associate Director of Patient Engagement
The Michael J. Fox Foundation for Parkinson’s Research
A perspective on digital law
JAN BENEDIKT BRÖNNEKE
Director, Law & Economics Health Technologies health innovation hub
A perspective on improving software and experience for clinical trial sites
BRADFORD HIRSCH
Chief Executive Officer
SignalPath Research
11:55 a.m. Charge to the Breakout Groups
12:00 p.m. “Lightning Round” Breakout Discussion Groups (25 min)
The breakout groups will be assigned one of the two following goals and asked to discuss practical applications and partnerships with new technologies that can address key priority challenges, and opportunities aligned with this goal that will move us toward the clinical trials enterprise envisioned for 2030. See associated breakout discussion guides for more detail.
  • GOAL 1: Enable a more person-centered and easily accessible clinical trials enterprise. This also relates to the vision of the Clinical Trials Transformation Initiative for 2030: https://www.ctti-clinicaltrials.org/transforming-trials-2030
  • GOAL 2: Simplify trials (less data collection, fewer site visits) and lower costs while still generating high-quality data and robust answers to relevant research questions.
12:25 p.m. Breakout Group Wrap-Up
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

FIRESIDE CHAT

12:30 p.m. Fireside Chat
MARK MCCLELLAN
Director
Duke–Margolis Center for Health Policy
AMY ABERNETHY, Moderator
Former Principal Deputy Commissioner of Food and Drugs
U.S. Food and Drug Administration
1:00 p.m. BREAK (30 min)

SESSION II
THE ROAD TO 2030: A CALL TO ACTION

ANITA ALLEN, Moderator
Henry R. Silverman Professor of Law, Professor of Philosophy
University of Pennsylvania Carey Law School
1:30 p.m. Frontline Experience: A Road Already Traveled
JANICE CHANG
Chief Operating Officer
TransCelerate BioPharma Inc.
PAMELA TENAERTS
Chief Scientific Officer
Medable
1:50 p.m. Charge to the Breakout Groups
2:00 p.m. “Lightning Round” Breakout Discussion Groups (25 min)
The breakout groups will be assigned one of the two following goals and asked to discuss practical applications and partnerships with new technologies that can address key priority challenges, and opportunities aligned with this goal that will move us toward the clinical trials enterprise envisioned for 2030.
  • GOAL 3: Establish a clinical trials enterprise that is diverse, equitable, and inclusive.
  • GOAL 4: Establish a national network of community-based clinical trial sites.
2:25 p.m. Breakout Group Wrap-Up
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

CLOSING PANEL

2:35 p.m. A “North-Star” Vision of What Is Possible
ANDY CORAVOS
Chief Executive Officer and Co-Founder
Elektra Labs
ERIC PERAKSLIS
Chief Science and Digital Officer
Duke Clinical Research Institute
SAM ROOSZ
Co-Founder and Chief Executive Officer
Crescendo Health
2:55 p.m. Workshop Wrap-Up
STEVEN GALSON, Workshop Co-Chair
Senior Vice President, Research & Development
Amgen Inc.
ESTHER KROFAH, Workshop Co-Chair
Executive Director
FasterCures, Milken Institute
3:00 p.m. ADJOURN
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 107
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 108
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 109
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 110
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 111
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 112
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 113
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 114
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 115
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 116
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 117
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 118
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 119
Suggested Citation:"Appendix C: Workshop Agendas." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 120
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The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.

Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.

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