Design and Evaluation of Clinical Trials for PTSD: A VA, NIMH, DOD Working Group
January 22, 2008 – January 23, 2008
Department of Veterans Affairs, Office of Research and Development (VA)
National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
Department of Defense, Health Affairs (DOD)
Military actions in Afghanistan and Iraq and numerous natural disasters in the U.S. have focused attention on the mental health needs of and adequacy of services for impacted populations. A major emphasis of this attention has centered on the effectiveness of treatments for Posttraumatic Stress Disorder (PTSD). A 2007 Institute of Medicine (IOM) review of the literature on treatments for PTSD among military, veteran, and civilian populations revealed that there are challenges to research on the development and testing of various intervention approaches. NIMH joined the Department of Veterans Affairs, Office of Research and Development, and the Department of Defense, Health Affairs, in organizing a two day working group to review, in the context of the recent IOM report, generally agreed upon standards for clinical trials in biomedical and behavioral research; discuss some of the clinical and research challenges associated with clinical trials for PTSD; and develop expert advice for surmounting these challenges in future intervention trials for PTSD. The working group meeting involved academic, VA and DOD clinicians, researchers, and administrators with expertise in PTSD clinical phenomenology, clinical trial research design, statistical analyses, and health science administration. The meeting was organized around three focal areas: 1) design and analysis considerations, 2) choosing outcome measure(s), and 3) facilitating successful trial implementation. The overall goal was to enhance the foundation for developing and evaluating future PTSD interventional studies in the form of practical suggestions for researchers and expert reviewers. The proceedings of this meeting are forthcoming, to be framed as answers to questions the participants addressed during the meeting and presented as issues to be considered in the design, implementation, and analysis of clinical trials. For more information, please contact Dr. Farris Tuma, Dr. Robert Heinssen , or Dr. Shoshana Kahana .