Abstracts from the ICBM 2012 Meeting
DESIGN AND EXECUTION OF RANDOMIZED CLINICAL TRIALS INVOLVING BEHAVIORAL INTERVENTIONS – Part I.
Kaufmann P. G.1, Powell L. H.2, Freedland K. E.3
1National Heart, Lung and Blood Institute, Bethesda, MD, USA
2Rush University Medical Center, Chicago, IL, USA
3Washington University, St. Louis, MO, USA
Randomized controlled trials are the gold standard for evaluating efficacy and effectiveness of interventions in biomedical clinical research. Their implementation in behavioral medicine poses specific challenges that warrant careful consideration.
This workshop is designed to provide a basic overview of the most salient principles that underlie the conduct of valid randomized behavioral clinical trials. Material will include a discussion of equipoise and blinding, efficacy and effectiveness, pragmatic trials, large simple trials, multisite trials, relationship of pilot studies to outcomes in the main trial, a consideration of Phases of trials, applicability of “Good Clinical...