title: Approaches to multisite clinical trials: the National Institute of Mental Health perspective.
abstract: 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.
authors.affiliation: Adult and Geriatric Treatment and Preventive Intervention Research Branch, Division of Services and Intervention Research, National Institute of Mental Health, Bethesda, MD 20892-9635, USA. blebowit@mail.nih.gov
authors.forename: Barry D
authors.initials: BD
authors.lastname: Lebowitz
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.forename: Grayson S
authors.initials: GS
authors.lastname: Norquist
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D008605:Mental Health Services / Q000458:organization & administration; D015337:Multicenter Studies as Topic / Q000592:standards*; D009315:National Institute of Mental Health (U.S.); D011634:Public Health; D014481:United States