Improving the design and analytic methods used in NIH-funded clinical trials involving behavioral interventions

Abstract

Behavioral interventions are widely used in clinical trials supported by the National Institutes of Health (NIH). When behavioral interventions involve group-formatted components and/or shared interventionists, they require special design and analytic methods not needed in trials that do not involve these features. The NIH Office of Disease Prevention (ODP) and the NIH Office of Behavioral and Social Sciences Research (OBSSR) offer resources to make it easier for investigators to use appropriate methods to evaluate these interventions. This commentary draws attention to these issues and highlights the ODP and OBSSR resources available to investigators. We urge investigators to take advantage of these resources to learn about and adopt appropriate sample size and analytic methods for trials to evaluate behavioral interventions so that their results will be reliable and reproducible. That is the best way to advance the science of behavioral interventions to improve health.

Keywords: analytic methods; behavioral intervention; sample size methods; study design.