• 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

 

KELLY POSNER

Director

Center for Suicide Risk Assessment

New York State Psychiatric Institute

9:55 a.m.

Perspectives from the Patient Community

 

GAIL GRIFFITH

Consumer Representative

Food and Drug Administration’s

Psychopharmacological Drug Advisory Committee



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement