Virtual Clinical Trials: Challenges and Opportunities - A Workshop

When: November 28, 2018 - November 29, 2018 (8:30 AM Eastern)
Where: National Academy of Sciences Building (Lecture Room) • 2101 Constitution Avenue, NW, Washington, DC 20418

Topic Biomedical and Health Research
Activity: Forum on Drug Discovery, Development, and Translation
Board: Board on Health Sciences Policy


    Virtual Clinical Trials: Challenges and Opportunities - A Workshop


    Wednesday, November 28, 2018 | 1:00 p.m. - 5:00 p.m. 
    Thursday, November 29, 2018 | 8:30 a.m. - 3:00 p.m.

    National Academy of Sciences
     Lecture Room
    2101 Constitution Avenue, NW
    Washington, DC 20418



    Workshop Background and Format

    Clinical trials are a cornerstone of medical product development – supporting the evaluation of efficacy and identification of safety issues of new drugs – and a necessary regulatory requirement for bringing novel therapies to market. This workshop will provide a venue to explore opportunities for a modern, patient-centric clinical trials enterprise in light of digital health tools that could allow virtual clinical trials – e.g., studies that deploy various digital health tools or remote site visits – for new medical product approval. At this workshop, subject matter experts will engage in presentations and discussions to:

      • Explore the current clinical trials infrastructure and highlight opportunities for improvement to support virtual clinical trials, including:

        • potential implications of virtual trials on cost, speed, regulation, and knowledge generation and dissemination of clinical trials; and

        • elements of an IT infrastructure, such as integrating data from electronic health records, mobile health applications, remote monitoring, virtual visits, and other relevant technologies with the capability to enhance the interface between clinicians and clinical trial participants.     

      • Explore potential opportunities to use digital health tools to improve participation in trials, including:

        • collaborative approaches and incentives involving sponsors, researchers, patient advocacy groups, patients living with the particular condition being studied, and health systems – including regulations, quality measures and outcomes, or reimbursement strategies – to support the implementation of virtual clinical trials; and

        • opportunities and challenges to enhancing equity in access and participation.   


        Workshop Planning Committee Roster

          • Linda Brady (co-chair), National Institute of Mental Health, National Institutes of Health

          • S. Claiborne Johnston (co-chair), University of Texas, Austin

          • Steven Anderson, U.S. Food and Drug Administration

          • Robert Califf,  Duke University, Verily Life Sciences

          • Joshua Denny, Vanderbilt University Medical Center

          • Robert Gentleman, 23andMe, Inc.

          • Robert Goodwin, Pfizer, Inc.

          • Kathy Hudson, People-Centered Research Foundation

          • David Ledbetter, Geisinger

          • David McCallie,  Cerner Corporation

          • Rebecca D. Pentz,  Winship Cancer Center, Emory University School of Medicine

          • Leonard Sacks, U.S. Food and Drug Administration

          • Todd Sherer, Michael J. Fox Foundation for Parkinson’s Research

          • Kelly Simcox, Sanofi

          • John Wilbanks, Sage Bionetworks




      Upcoming Meetings for this Activity

      Previous Meetings for this Activity

      Also of Interest