Neuropsychiatric Clinical Trials: Should They Accommodate... : Journal of Clinical Psychopharmacology (original) (raw)

Review Article

Should They Accommodate Real-World Practices or Set Standards for Clinical Practices?

From the Drug Design and Development Section, Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD.

Received April 29, 2008; accepted after revision October 17, 2008.

Reprints: Robert E. Becker, MD, CM, c/o Nigel Greig, Drug Design and Development Section, Laboratory of Neurosciences, 5th floor BRC Bldg, 251 Bayview Blvd, Baltimore, MD 21224 (e-mail: [email protected]).

The authors are supported in part by the Intramural Research Program of the National Institute on Aging, National Institutes of Health. The authors have received no other funding for this work and have no financial conflicts of interest. The views expressed within this article are those of the authors and may not represent those of the National Institute on Aging, National Institutes of Health.

Abstract

Evidence-based psychiatry seeks the best research evidence for use in patient care. Recent research suggests that problems with accuracy, precision, bias, and other sources of unreliability potentially interfere with the validity of psychiatry's evidence base. Because many negative clinical research studies go unpublished, awareness and fuller understanding of these problems are blocked by lack of access to relevant data. Based on the importance of scientific soundness of neuropsychiatric research and patient care, we argue for increased attentiveness by investigators and practitioners to how clinical trials (CTs) interdependently estimate the efficacy of treatments and the effectiveness of methods as fair tests of efficacy. Deference by CT investigators to real-world practice conditions at research sites because of the unreliability introduced into data by these practices does not ensure unbiased evaluations of treatment efficacy. We argue for more systematic attention to sources of unreliability in CT investigations and increased commitments to assure the validity of the neuropsychiatric evidence base. These recommendations aim to determine neuropsychiatric drug efficacy with greater certainty to better quantify the clinical importance of drug-associated effects and to provide CT-evidenced guidance for practitioners to most effectively use drug efficacy in patient care.