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Improving Clinical Trials
American Society of Clinical Psychopharmacology Recommendations
Donald F. Klein, MD;
Michael E. Thase, MD;
Jean Endicott, PhD;
Lawrence Adler, MD;
Ira Glick, MD;
Amir Kalali, MD;
Steven Leventer, PhD;
Jeffrey Mattes, MD;
Peter Ross;
Alexander Bystritsky, MD
Arch Gen Psychiatry. 2002;59:272-278.
The major purpose of this American Society of Clinical Psychopharmacology-sponsored
meeting was to identify strategies for more efficiently detecting clinical
drug effects, thus reducing the economic and scientific risks of investigating
new chemical entities in psychiatric disorders. The meeting consisted of presentations
and discussions by experts who repeatedly had difficulty pursuing scientific,
public health–relevant goals. Many approaches to improving the detection
of potentially beneficial agents were reviewed. In this article, we discuss
technically feasible study improvements. The scope of inquiry included identifying
means of shifting institutional and regulatory assumptions and processes,
even to the point of seeking appropriate national incentives.
From the New York State Psychiatric Institute, New York (Drs Klein
and Endicott); University of Pittsburgh Medical Center and Western Psychiatric
Institute and Clinic, Pittsburgh, Pa (Dr Thase); Clinical Insights, Glen Burnie,
Md (Dr Adler); Stanford University School of Medicine, Stanford, Calif (Dr
Glick); Quintiles Inc, San Diego, Calif, and the University of California,
Irvine (Dr Kalali); Vela Pharmaceuticals, Lawrenceville, NJ (Dr Leventer);
Psychopharmacology Research of Princeton, Princeton, NJ (Dr Mattes); the American
Society of Clinical Psychopharmacology Inc and the National Foundation for
Depressive Illness, New York (Mr Ross); and the University of California,
Los Angeles (Dr Bystritsky). Although all authors have extensive contacts
with industry, the focus of this article is methodological.
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