Improving clinical trials: American Society of Clinical Psychopharmacology recommendations.
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.
Klein
Donald F
DF
New York State Psychiatric Institute and Columbia University, Unit 22, 1051 Riverside Dr, New York, NY 10032, USA. dfk2@columbia.edu
Thase
Michael E
ME
Endicott
Jean
J
Adler
Lawrence
L
Glick
Ira
I
Kalali
Amir
A
Leventer
Steven
S
Mattes
Jeffrey
J
Ross
Peter
P
Bystritsky
Alexander
A
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D004195:Disease Models, Animal; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004989:Ethics; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D011619:Psychotropic Drugs