Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

by Richard S. E. Keefe, PhD; Helena C. Kraemer, PhD; Robert S. Epstein, MD, MS; Ellen Frank, PhD; Ginger Haynes, PhD; Thomas P. Laughren, MD; James McNulty, AbScB; Shelby D. Reed, PhD; Juan Sanchez, MD; and Andrew C. Leon, PhD
Dr. Keefe is Professor of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina; Dr. Kraemer is with Stanford University (Emerita), Stanford, California, and University of Pittsburgh, Pittsburgh, Pennsylvania; Dr. Epstein is with Epstein Health, Woodcliff Lake, New Jersey; Dr. Frank is with the Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; Dr. Haynes is with Eli Lilly and Company, Indianapolis, Indiana; Dr. Laughren is with Laughren Psychopharm Consulting, LLC, Rockville, Maryland; Dr. McNulty is Executive Director at MHCA/OASIS-RI, Providence, Rhode Island; Dr. Reed is with Duke Clinical Research Institute, Durham, North Carolina; Dr. Sanchez is Analyst, Ladenburg Thalmann & Co., New York, New York; and Dr. Leon was Professor of Biostatistics in Psychiatry at Weill Cornell Medical College, New York, New York.

Innov Clin Neurosci. 2013;10(5–6 Suppl A):4S–19S