Global contract research organization (CROO) PPD Inc. has landed funding for a five-year plan to design and deploy an adaptive platform clinical research study of various drug interventions intended to treat post-traumatic stress disorder (PTSD). The CRO will work with the US Army Medical Materiel Development Activity’s (USAMMDA) Warfighter Brain Health Project Management Office (WBH PMO) to test the effectiveness and safety of at least two pharmacotherapeutic drug candidates for treating PTSD in active-duty personnel as well as veterans.
The RPA is part of the Medical Technology Enterprise Consortium (MTEC), which is under an Other Transaction Authority with the USAMRDC. As an MTEC member, PPD supports ongoing efforts to expand and grow additional important public health research programs like PTSD for the Department of Defense (DoD) and Army.
Stephen Peroutka, vice president and global therapeutic area head of neuroscience for PPD (and former chief of neurology for the Palo Alto VA Medical Center) told Outsourcing-Pharma his company has a history of working with the US government and military on various studies.
“Since 1990 PPD has provided clinical research support to the US government’s Department of Health and Human Services (DHHS), as well as the DoD,” he said. "Within the last 10 years, PPD’s dedicated government and public health services team has provided full-service, multi-service and single-service clinical, regulatory and quality support to the USAMMDA.
PTSD is a mental condition affecting about 8m Americans annually. While veterans can develop the disorder after experiencing or witnessing combat, civilians also can develop PTSD after life-threatening or otherwise unsettling events.
According to the VA’s National Center for PTSD, up to 30% of veterans have had PTSD in their lifetimes. Currently, there are only two FDA-approved drugs designated to treat PTSD, both approved nearly 20 years ago—and, Peroutka commented, people suffering from the ailment deserve more effective treatments.
“PTSD is a major unmet medical need, particularly for the men and women who serve in the US military,” he said. “Our adaptive platform trial will offer an innovative, cost-effective and much-needed approach to PTSD drug development, with an end goal of delivering efficacious drugs to treat this major unmet medical need.”
PPD’s planned adaptive platform trial design reportedly will give the WBH PMO increased efficiency, as well as a streamlined development process for the clinical program. The trial design will aim to facilitate evaluation of multiple experimental treatment options simultaneously, add new treatments over time, end ineffective treatments and move promising treatments to the next phase of development.
The PPD neuroscience clinical and medical experts involved in the studies are former VA attending psychiatrists and physicians with experience treating active-duty service members and veterans diagnosed with PTSD. Additionally, the leader of PPD’s government and public health services team overseeing the company’s team of PTSD-focused experts is a retired Army veteran that has direct experience with PTSD sufferers.