Neuroscience Trials of the Future Proceedings of a Workshop (2016) / Chapter Skim
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Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 79-90
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From page 79... ...
Signal detection in central nervous system trials is regularly beset by high placebo or nonspecific response, intrasubject variability of endpoints, intersubject and intersite variability in multicenter trials, poor treatment adherence, and weak patient engagement and retention. The net effect of these challenges has been to simply increase the trial sample size in an attempt to control type II error.
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in neuroscience clinical trials is needed. Given the current challenges in neuroscience clinical trials, this public workshop will bring together key stakeholders to discuss opportunities to improve the integrity, efficiency, and validity of clinical trials for nervous system disorders (focusing specifically on Phase II and Phase III trials)
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March 3, 2016 8:30 a.m. Opening Remarks ATUL PANDE, workshop co-chair Chief Medical Officer and Executive Vice President Tal Medical RICHARD KEEFE, workshop co-chair Professor of Psychiatry and Behavioral Sciences Duke University School of Medicine Neuroscience Clinical Trials: Challenges and Opportunities 8:45 a.m.
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10:00 a.m. Session Overview and Objectives STEPHEN BRANNAN, session moderator Vice President of Clinical Research and Medical Affairs Forum Pharmaceuticals Biomarkers 10:10 a.m.
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MICHAEL PENCINA Director of Biostatistics, Duke Clinical Research Institute Professor of Biostatistics and Bioinformatics Duke University Novel Clinical Trial Designs 11:25 a.m. ERIK SNOWBERG Professor of Economics and Political Science California Institute of Technology SYLVAIN CHASSANG Professor of Economics and Public Affairs Princeton University 11:45 a.m.
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LUNCH SESSION II: CLINICAL TRIAL METHODOLOGY Session Objectives: Explore opportunities to improve clinical trial methodology for nervous system disorders, including strategies for patient selection, engagement, and retention. Examine the extent to which current diagnostic methods contribute to the inherent variability in study populations.
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What are the scientific controversies behind this evidence? CARLOS RODARTE Chief Executive Officer Health Rhythms JOHN REITES Head, Digital Health Acceleration Quintiles DREW SCHILLER Chief Technology Officer and Co-Founder Validic GLEN DE VRIES President and Co-Founder Medidata Solutions, Inc.
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Day Two Opening ATUL PANDE, workshop co-chair Chief Medical Officer and Executive Vice President Tal Medical RICHARD KEEFE, workshop co-chair Professor of Psychiatry and Behavioral Sciences Duke University School of Medicine
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BREAK SESSION IV: ETHICAL CONSIDERATIONS Session Objectives: Examine ethical, legal, and social questions about neuroscience clinical trials. Consider potential data protection and human subjects' issues that might arise as clinical trials continue to transform.
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FRANK ROCKHOLD Senior Vice President, Global Clinical Safety and Pharmacovigilance GlaxoSmithKline Professor of Biostatistics and Bioinformatics (starting March 2016) Duke University School of Medicine Human Subjects Protection 11:25 a.m.
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From page 89... ...
PAUL STANG Vice President, Global R&D Epidemiology Janssen Research and Development Pragmatic Trials: Challenges and Opportunities for Neuroscience Trials 1:55 p.m. MARK CZIRAKY Co-Founder and Vice President of Research HealthCore, Inc.
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From page 90... ...
3:00 p.m. Panel Discussion: Session Moderators ATUL PANDE, workshop co-chair RICHARD KEEFE, workshop co-chair STEPHEN BRANNAN, session I moderator AMIR KALALI, session II moderator THOMAS LAUGHREN, session III moderator PETRA KAUFMANN, session IV moderator DANIEL BURCH AND MICHAEL POLLOCK, session V moderators 3:45 p.m.
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