Advancing Research Standards for PTSD Interventions: Suggested Approaches for Designing and Evaluating Clinical Trials

Congressionally Mandated Research Program) convened a group of scientific experts and research administrators to develop approaches for overcoming challenges in conducting rigorous interventional research in persons with posttraumatic stress disorder (PTSD). Method: Experts were asked to consider issues raised by the Institute of Medicine (I OM) report titled Treatment of PTSD: An Assessment of the Evidence (2008) and to address specific questions related to clinical trial design and analysis; the selection, use, and interpretation of measures designed to assess PTSD; and trial implementation. At the 2-day meeting, facilitators led discussions of questions developed by organizers, and experts deliberated to develop suggested approaches. Results: Suggestions were developed for clinical trial design and analysis, PTSD measurement, and trial implementation. Specific suggested approaches included alignment of study design and appropriate endpoints with study objectives, adherence to study protocol, broad inclusion criteria for study participants, and appropriate selection of control groups. Additional discussion focused on approaches to including subjects with incomplete data in study results, the importance of applying prespecified strategies for addressing missing data and strategies for followup investigations, the use of self-report measures, and subject reimbursement. Conclusions: Many of the suggested approaches may be applicable to psychiatric interventional research globally. In the case of PTSD, these approaches could provide a foundation for researchers and scientific reviewers to use in designing and evaluating future interventional studies, thereby strengthening the evidence base for PTSD treatment approaches across multiple populations.