Moving Treatment Research from Clinical Trials to the Real World

Published in: Psychiatric Services, v. 54, no. 3, Mar. 2003, p. 327-332

by Peter Roy-Byrne, Cathy D. Sherbourne, Michelle G. Craske, Murray Stein, Wayne J. Katon, Greer Sullivan, Adrienne Means-Christensen, Alexander Bystritsky

Read More

Access further information on this document at

This article was published outside of RAND. The full text of the article can be found at the link above.

Recently the National Institutes of Health has been emphasizing research that takes findings generated by clinical research and translates them into treatments for patients who are seen in day-to-day nonresearch settings. This translational process requires a series of steps in which elements of both efficacy and effectiveness research are combined into successively more complex designs. However, there has been little discussion of exactly how to develop and operationalize these designs. This article describes an approach to the development of these hybrid designs. Their operationalization is illustrated by using the design of an ongoing effectiveness treatment study of panic disorder in primary care. Experts in both efficacy and effectiveness research collaborated to address the methodologic and data collection issues that need to be considered in designing a first-generation effectiveness study. Elements of the overall study design, setting or service delivery context, inclusion and exclusion criteria, recruitment and screening, assessment tools, and intervention modification are discussed to illustrate the thinking behind and rationale for decisions about these different design components. Although the series of decisions for this study were partly influenced by considerations specific to the diagnosis of panic disorder and the context of the primary care setting, the general stepwise approach to designing treatment interventions using an effectiveness model is relevant for the development of similar designs for other mental disorders and other settings.

This report is part of the RAND Corporation External publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations.

Our mission to help improve policy and decisionmaking through research and analysis is enabled through our core values of quality and objectivity and our unwavering commitment to the highest level of integrity and ethical behavior. To help ensure our research and analysis are rigorous, objective, and nonpartisan, we subject our research publications to a robust and exacting quality-assurance process; avoid both the appearance and reality of financial and other conflicts of interest through staff training, project screening, and a policy of mandatory disclosure; and pursue transparency in our research engagements through our commitment to the open publication of our research findings and recommendations, disclosure of the source of funding of published research, and policies to ensure intellectual independence. For more information, visit

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.