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Virtual Clinical Trials Challenges and Opportunities: Proceedings of a Workshop (2019) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 79-86

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From page 79...
... • Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruit ment of participants to join a clinical trial, and maintain participa tion of diverse populations in the trial, including 79
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From page 80...
... • How could virtual clinical trials improve traditional Phase 3 clini cal 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
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From page 81...
... • Discuss challenges and best practices for designing and implement ing 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
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From page 82...
... 82 VIRTUAL CLINICAL TRIALS 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
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From page 83...
... 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
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From page 84...
... 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
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From page 85...
... APPENDIX A 85 Session V: Potential Future Directions Session Objective: • Discuss key highlights from the workshop presentations and dis cussions, 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
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Key Terms

  • virtual clinical
  • clinical trial
  • virtual trials
  • medical product
  • clay johnston

  • linda brady
  • clinical care
  • digital health
  • health tools
  • observational studies

  • emory university
  • francisco coordinating
  • transformation initiative
  • trials improve
  • conduct increasingly

  • overall medical
  • interventional virtual
  • improve traditional
  • explore potential
  • tual clinical

  • trials transformation
  • potential research
  • minority health
  • traditional phase
  • irtual clinical

  • kelly simcox
  • research participants
  • coordinating center
  • clinical methodology
  • potential opportunities


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