Approaches to multisite clinical trials: the National Institute of Mental Health perspective

The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing t...

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Veröffentlicht in:Schizophrenia bulletin 2003, Vol.29 (1), p.7-13
Hauptverfasser: Lebowitz, Barry D, Vitiello, Benedetto, Norquist, Grayson S
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creator Lebowitz, Barry D
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description The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them.
doi_str_mv 10.1093/oxfordjournals.schbul.a006992
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source MEDLINE; EBSCOhost APA PsycARTICLES; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Oxford Journals
subjects Clinical Trials
Clinical Trials as Topic - standards
Empirical Methods
Experimental Design
Human
Humans
Mental Disorders - therapy
Mental Health Services - organization & administration
Multicenter Studies as Topic - standards
National Institute of Mental Health (U.S.)
Professional Organizations
Public Health
United States
title Approaches to multisite clinical trials: the National Institute of Mental Health perspective
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