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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation; Shore C, Khandekar E, Alper J, editors. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2019 Jul 23.
Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop.
Show details- Virtual Clinical Trials: Challenges and Opportunities
- November 28–29, 2018
- National Academy of Sciences Building, Lecture Room
- 2101 Constitution Avenue, NW, Washington, DC 20418
This workshop will examine opportunities for a modern, patient-centric clinical trials enterprise in light of digital health tools that could allow a virtual clinical trial for new medical product approval. Subject-matter experts will engage in presentations and discussions to:
- Highlight opportunities for systemic improvements to support virtual clinical trials, including
- Potential implications of virtual clinical trials for cost, speed, regulation, and knowledge generation and dissemination; and
- Elements of an information technology infrastructure, including 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 engage with patients and potential research participants, facilitate recruitment of participants to join a clinical trial, and maintain participation of diverse populations in the trial, 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 through virtual clinical trials.
DAY ONE: NOVEMBER 28
1:00 pm | Welcome and Opening Remarks |
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Session I: Opportunities to Improve Clinical Trials
Session Objectives:
- Consider the efficiency and effectiveness of the current clinical trials landscape in the United States—what is working and not working well?
- How could virtual clinical trials improve traditional Phase 3 clinical trials and overall medical product development?
Session Co-Chairs:
- Linda Brady, National Institutes of Health
- Clay Johnston, The University of Texas at Austin
1:10 pm |
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1:50 pm | Discussion with Workshop Participants |
Session II: Exploring Virtual Clinical Trials
Session Objectives:
- Hear a variety of perspectives and experiences with virtual and digital health technologies in interventional and observational studies, as well as clinical care, and highlight opportunities to use these technologies to improve clinical trials of investigational products.
- Discuss challenges and best practices for designing and implementing a virtual clinical trial.
Session Chair:
- Kelly Simcox, Sanofi
2:15 pm | Lessons Learned from Clinical Care |
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2:30 pm | Lessons Learned from Observational Studies |
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2:45 pm | Discussion with Workshop Participants |
3:00 pm | BREAK |
3:15 pm | Lessons Learned from Interventional Virtual Clinical Trials |
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4:00 pm | Panel Discussion and Reactions |
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4:30 pm | Discussion with Workshop Participants |
5:00 pm | Adjourn Day One |
DAY TWO: NOVEMBER 29
8:30 am | Breakfast |
8:45 am | Welcome and Recap Day One |
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Session III: Access and Equity
Session Objectives:
- Consider how to frame issues of access and equity in the context of virtual trials. Could virtual trials potentially exacerbate current inequities or make access to clinical trials worse for some communities?
- Discuss the potential benefits and risks of end-to-end virtual clinical trials for traditionally underrepresented populations in research.
Session Co-Chairs:
- Kathy Hudson, People-Centered Research Foundation
- Rebecca Pentz, Emory University School of Medicine
9:00 am |
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10:00 am | Discussion with Workshop Participants |
10:30 am | BREAK |
Session IV: Policy Considerations
Session Objectives:
- Discuss existing, and yet to be conceived, policies and standards governing virtual clinical trials for medical product development.
- What are the challenges and potential solutions surrounding the collection of remote data from participants—including how to ensure the data collected are coming from the person you think it is, and how to know they are using the device correctly—all while protecting privacy?
- Consider the landscape of standards and any gaps that may need to be addressed in order to conduct increasingly virtual trials.
Session Co-Chairs:
- David McCallie, Cerner Corporation
- John Wilbanks, Sage Bionetworks
10:45 am |
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11:45 am | Discussion with Workshop Participants |
12:30 pm | LUNCH |
Session V: Potential Future Directions
Session Objective:
- Discuss key highlights from the workshop presentations and discussions, including identifying potential next steps and promising areas for future action.
Session Co-Chairs:
- Linda Brady, National Institutes of Health
- Clay Johnston, The University of Texas at Austin
1:15 pm | Observations from the Workshop and Potential Future Directions |
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2:15 pm | Discussion with Workshop Participants |
3:00 pm | Workshop Adjourn |
- Workshop Agenda - Virtual Clinical TrialsWorkshop Agenda - Virtual Clinical Trials
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