Meeting Summary
Design and Evaluation of Clinical Trials for PTSD: A VA, NIMH, DOD Working Group
January 22, 2008 – January 23, 2008
Rockville, Maryland
Sponsored by:
Department of Veterans Affairs, Office of Research and Development (VA)
National Institute of Mental Health (NIMH), National Institutes of Health
Department of Defense, Health Affairs (DOD)
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 .
A detailed meeting report is available (PDF file, 19 pages).