Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• PLANNING COMMITTEE ON VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acknowledgments
• Acronyms and Abbreviations
• 1. Introduction
  • DEFINING VIRTUAL CLINICAL TRIALS
  • ORGANIZATION OF THE PROCEEDINGS OF A WORKSHOP
• 2. Opportunities to Improve Clinical Trials
  • A PATIENT PERSPECTIVE
    Donna Cryer, President and CEO.
  • AN INDUSTRY PERSPECTIVE
    Craig Lipset, Head of Clinical Innovation.
  • AN ACADEMIC PERSPECTIVE
    Ray Dorsey, Director.
  • DISCUSSION
• 3. Exploring Virtual Clinical Trials
  • LESSONS LEARNED FROM CLINICAL CARE
    Jenna Bollyky, Vice President for Clinical Research and Analytics.
  • LESSONS LEARNED FROM OBSERVATIONAL STUDIES
    Joshua Denny, Professor of Biomedical Informatics and Medicine.
  • LESSONS LEARNED FROM INTERVENTIONAL STUDIES
  • PANEL REACTIONS
    Noah Craft, CEO.
  • DISCUSSION
• 4. Access and Equity
  • A PATIENT PERSPECTIVE
    Will McIntyre, Patient Advocate.
  • RECRUITMENT FOR CLINICAL TRIALS
    Sally Okun, Vice President of Policy and Ethics.
  • UNDERSERVED COMMUNITY OUTREACH AND ENGAGEMENT
    Silas Buchanan, CEO.
  • LESSONS LEARNED FROM BEHAVIORAL INTERVENTIONS
    Sherine El-Toukhy, Earl Stadtman Investigator.
  • DISCUSSION
• 5. Policy Considerations
  • A REGULATORY PERSPECTIVE
    Leonard Sacks, Associate Director for Clinical Methodology.
  • CLINICAL TRIALS TRANSFORMATION INITIATIVE: DECENTRALIZED CLINICAL TRIALS PROJECT
    Leanne Madre, Director of Strategy.
  • PRIVACY PROTECTIONS FOR VIRTUAL CLINICAL TRIALS
    Deven McGraw, General Counsel and Chief Regulatory Officer.
  • INFORMED CONSENT FOR PASSIVE DATA COLLECTION
    Matthew McIntyre, Senior Scientist.
  • DISCUSSION
• 6. Reflections on the Workshop and Potential Future Directions
  • SESSION 1: OPPORTUNITIES TO IMPROVE CLINICAL TRIALS
  • SESSION 2: EXPLORING CLINICAL TRIALS
  • SESSION 3: ACCESS AND EQUITY
  • SESSION 4: POLICY CONSIDERATIONS
  • NEXT STEPS
• References
• Appendix A. Workshop Agenda
• Appendix B. Workshop Speaker Biographical Sketches
• Appendix C. Examples of Virtual Clinical Trials Included in the Workshop Handout
• Appendix D. Virtual Clinical Trials Presented by Speakers at the Workshop

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2019. Virtual clinical trials: Challenges and opportunities: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25502.

Digital Object Identifier: https://doi.org/10.17226/25502

Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

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