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Appendix A Workshop Agenda Virtual Clinical Trials: Challenges and Opportunities November 28â29, 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: â¢ Highlight opportunities for systemic improvements to support virtual clinical trials, including: o Potential implications of virtual clinical trials for cost, speed, regulation, and knowledge generation and dissemination; and o Elements of an IT infrastructure, including integrating data from EHRs, mobile health applications, remote monitoring, virtual visits, and other relevant technologies with the capability to enhance the interface between clinicians and clinical trial participants. â¢ 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: o Collaborative approaches and incentives involving sponsors, researchers, patient advocacy groups, patients living with the particular condition being studied, and health systemsâincluding regulations, quality measures and outcomes, or reimbursement strategiesâto support the implementation of virtual clinical trials; and opportunities and challenges to enhancing equity in access and participation through virtual clinical trials. PREPUBLICATION COPY: UNCORRECTED PROOFS 65
66 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES 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: â Consider the efficiency and effectiveness of the current clinical trials landscape in the United Statesâwhat is working and not working well? â 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 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: â 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. â Discuss challenges and best practices for designing and implementing a virtual clinical trial. PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX A 67 Session Co-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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS
68 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES 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 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: â 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? â Discuss the potential benefits and risks of end-to-end virtual clinical trials for traditionally underrepresented populations in research. Session Co-Chairs: Kathy Hudson, Patient-Centered Research Foundation Rebecca Pentz, Emory University School of Medicine 9:00 am WILL MCINTYRE Patient Advocate The Michael J. Fox Foundation for Parkinsonâs Research SALLY OKUN Vice President, Policy and Ethics PatientsLikeMe PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX A 69 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 10:00 am Discussion with Workshop Participants 10:30 am BREAK Session IV: Policy Considerations Session Objectives: â Discuss existing, and yet to be conceived, policies and standards governing virtual clinical trials for medical product development. â 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 correctlyâall while protecting privacy? â Consider the landscape of standards and any gaps that may need to be addressed in order to conduct increasingly virtual trials. Session Co-Chairs: John Wilbanks, Sage Bionetworks David McCallie, Cerner Corporation 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 PREPUBLICATION COPY: UNCORRECTED PROOFS
70 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES 23andMe 11:45 am Discussion with Workshop Participants 12:30 pm LUNCH Session V: Potential Future Directions Session Objective: â 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 â¢ Linda Brady and Clay Johnston, Session I: Opportunities to Improve Clinical Trials â¢ Kelly Simcox, Session II: Exploring Virtual Clinical Trials â¢ Kathy Hudson and Rebecca Pentz, Session III: Access and Equity â¢ John Wilbanks and David McCallie, Session IV: Policy Considerations 2:15 pm Discussion with Workshop Participants 3:00 pm Workshop Adjourn PREPUBLICATION COPY: UNCORRECTED PROOFS