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Schizophrenia Bulletin 2000 26(3):533-541;
© 2000 by Oxford University Press and the Maryland Psychiatric Research Center (MPRC)
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© Oxford University Press

Pitfalls of Multisite Randomized Clinical Trials of Efficacy and Effectiveness

Helena Chmura Kraemer, Ph.D.
Professor of Biostatistics in Psychiatry, Stanford University Stanford, CA

Send reprint requests to Prof. H.C. Kraemer, Dept. of Psychiatry and Behavioral Sciences, MC 5717, Stanford University, 401 Quarry Rd., Stanford, CA 94305

This article discusses common pitfalls of multisite randomized clinical trials of efficacy and effectiveness. Issues considered include (1) premature initiation, (2) ineffective study structure, (3) too much or too little communication among researchers, (4) neglect of site differences, (5) use of "naked" p values, (6) premature closure, and (7) overreliance on the interpretation and memory of individual researchers. If future researchers are aware of these common pitfalls, they may be able to avoid them.

Keywords: Multisite studies / randomized clinical trials / research planning / research organization


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