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CNS Clinical Trials: Suicidality and Data Collection - Workshop Summary
Examine potential partnerships among the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data sharing from randomized clinical trials.
9:00 a.m.
Welcome, Introductions, and Workshop Objectives
WILLIAM POTTER, Workshop Co-chair
Vice President
Clinical Neuroscience
Merck Research Laboratories
Merck & Co., Inc.
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.
C-CASA and C-SSRS in CN S Clinical Trials: Development and Implementation