Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost of any psychological condition. It’s clear that more research must be conducted, and treatments developed, to address this unmet medical need. While there are currently more than 350 ongoing clinical research studies in PTSD, most are in the academic arena. Consequently, there is limited knowledge within industry on conducting these clinical trials. Having worked in PTSD research for several years, Premier Research understands the combination of expertise and nuance to achieve a successful clinical trial. Topics Covered • Study design considerations, including assessment frequency and target population (military versus civilian). • An overview of the CAPS-5 assessment, including the importance of the structured interview and alignment of the scoring rules. • Recruitment strategies and site dynamics unique to this indication.