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Schizophrenia Bulletin 2003 29(1):7-13;
© 2003 by Oxford University Press and the Maryland Psychiatric Research Center (MPRC)
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© Oxford University Press

Approaches to Multisite Clinical Trials: The National Institute of Mental Health Perspective

Barry D. Lebowitz, Ph.D., Benedetto Vitiello, M.D. and Grayson S. Norquist, M.D., M.S.P.H.
Chief, Adult and Geriatric Treatment and Preventive Intervention Research Branch Bethesda, MD
Chief, Child and Adolescent Treatment and Preventive Intervention Research Branch Bethesda, MD
Director, all at the Division of Services and Intervention Research, National Institute of Mental Health Bethesda, MD

Send reprint requests to Dr. B.D. Lebowitz, National Institute of Mental Health, 6001 Executive Boulevard, Room 7160, MSC 9635, Bethesda, MD 20892-9635; e-mail: blebowit{at}mail.nih.gov

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.

Keywords: Clinical effectiveness / public health / NIMH / research strategy


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