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Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
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Appendix A

Workshop Agenda

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
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
  • 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
LINDA BRADY, Workshop Co-Chair

National Institute of Mental Health, National Institutes of Health

CLAY JOHNSTON, Workshop Co-Chair

The University of Texas at Austin

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 RAY DORSEY

Professor of Neurology and Director, Center for Health and Technology

University of Rochester Medical Center

DONNA CRYER

President and Chief Executive Officer

Global Liver Institute

Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
CRAIG LIPSET

Head of Clinical Innovation, R&D

Pfizer Inc.

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
JENNA BOLLYKY

Vice President, Clinical Research and Analytics

Livongo Health

2:30 pm Lessons Learned from Observational Studies
JOSHUA DENNY

Professor of Biomedical Informatics and Medicine

Vanderbilt University

2:45 pm Discussion with Workshop Participants
3:00 pm BREAK
3:15 pm Lessons Learned from Interventional Virtual Clinical Trials
STEVEN CUMMINGS

Director, San Francisco Coordinating Center

Professor of Medicine, Epidemiology, and Biostatistics

University of California, San Francisco

Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
WENDY WEBER

Acting Deputy Director

National Center for Complementary and Integrative Health

National Institutes of Health

KIMBERLY HAWKINS

Clinical Sciences and Operations Project Leader Head

Sanofi Genzyme

4:00 pm Panel Discussion and Reactions
NOAH CRAFT

Chief Executive Officer

Science 37

ADRIAN HERNANDEZ

Vice Dean for Clinical Research

Duke University School of Medicine

Faculty Associate Director

Duke Clinical Research Institute

JON WHITE

Deputy National Coordinator for Health Information Technology

The Office of the National Coordinator for Health Information Technology

U.S. Department of Health and Human Services

JOSH ROSE

Vice President, Global Head of Strategy

IQVIA
4:30 pm Discussion with Workshop Participants
5:00 pm Adjourn Day One
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×

DAY TWO: NOVEMBER 29

8:30 am Breakfast
8:45 am Welcome and Recap Day One
LINDA BRADY, Workshop Co-Chair

National Institute of Mental Health, National Institutes of Health

CLAY JOHNSTON, Workshop Co-Chair

The University of Texas at Austin

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 WILL MCINTYRE

Patient Advocate

The Michael J. Fox Foundation for Parkinson’s Research

SALLY OKUN

Vice President, Policy and Ethics

PatientsLikeMe

SILAS BUCHANAN

Chief Executive Officer

Institute for eHealth Equity

SHERINE EL-TOUKHY

Post-Doctoral Research Associate

National Institute on Minority Health and Health Disparities

National Institutes of Health

Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
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 LEONARD SACKS

Associate Director for Clinical Methodology

Office of Medical Policy, Center for Drug Evaluation and Research

U.S. Food and Drug Administration

LEANNE MADRE

Director of Strategy

Clinical Trials Transformation Initiative

DEVEN MCGRAW

General Counsel and Chief Regulatory Officer

Ciitizen Corporation

MATTHEW MCINTYRE

Senior Scientist, Data Collection

23andMe

11:45 am Discussion with Workshop Participants
12:30 pm LUNCH
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×

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
  • Linda Brady and Clay Johnston, Session I: Opportunities to Improve Clinical Trials
  • Kelly Simcox, Session II: Exploring Virtual Clinical Trials
  • Kathy Hudson and Rebecca Pentz, Session III: Access and Equity
  • David McCallie and John Wilbanks, Session IV: Policy Considerations
2:15 pm Discussion with Workshop Participants
3:00 pm Workshop Adjourn
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×

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Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
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Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 80
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 81
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 82
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 83
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 84
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 85
Suggested Citation:"Appendix A: Workshop Agenda." 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: 10.17226/25502.
×
Page 86
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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.

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