CNS Clinical Trials Suicidality and Data Collection: Workshop Summary (2010) / Chapter Skim
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Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 51-60
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From page 51... ...
. • Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior, particularly in the short term.
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ROBERT GIBBONS, Workshop Co-chair Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago 9:15 a.m. FDA Policies and Perspectives: Suicidality Studies in IND THOMAS LAUGHREN Director Division of Psychiatry Products Food and Drug Administration 9:35 a.m.
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Is Preceded by Expressed Ideation: A Literature Review MATTHEW NOCK Associate Professor of Social Sciences Department of Psychology Harvard University Measurement of Suicide Ideation GREGORY BROWN Research Associate Professor of Clinical Psychology in Psychiatry Department of Psychiatry University of Pennsylvania
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Moderated Discussion with Attendees DAVID BRENT, Session Chair Professor Department of Psychiatry University of Pittsburgh School of Medicine Discussion Questions: • Does the C-SSRS measure what it says it measures? • Are there outcomes that should be assessed but are not?
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Panel Discussion: Data Analysis Strategies (Each presentation approximately 15 minutes) Potential Drawbacks in Existing Methodologies JOEL GREENHOUSE Professor Department of Statistics Carnegie Mellon University Design and Analytic Strategies for Modeling Suicidality ROBERT GIBBONS Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago Design and Analytic Strategies for Modeling Suicidality: An FDA Perspective MARC STONE Senior Medical Reviewer Division of Psychiatry Products Food and Drug Administration Studying Suicidality: From RCTs to OCER ROBERT VALUCK Professor Department of Clinical Pharmacy University of Colorado at Denver
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2:35 p.m. BREAK SESSION III: PARTNERSHIPS: OPPORTUNITIES FOR COLLABORATION Session Objective: Examine potential partnerships among the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data sharing from randomized clinical trials.
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SHAAVHRÉE BUCKMAN Acting Director, Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Are There Ways to Create Robust and Informative Datasets Through Pooling? CHARLES BEASLEY Chief Scientific Officer, Global Patient Safety Lilly Research Laboratories Eli Lilly and Company
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4:30 p.m. Summary Remarks WILLIAM POTTER, Workshop Co-chair Vice President, Clinical Neuroscience Merck Research Laboratories
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APPENDIX B 59 ROBERT GIBBONS, Workshop Co-chair Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago 4:50 p.m. Open Discussion with Attendees 5:10 p.m.
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