contractpharmaFebruary 20, 2021
PPD, Inc., a global CRO, has been awarded Defense Health Agency funds to support a five-year Research Project Award (RPA) to develop and execute an adaptive platform clinical research trial of drug interventions to treat post-traumatic stress disorder (PTSD). PPD will work with U.S. Medical Research Development Command U.S. Army Medical Materiel Development Activity’s Warfighter Brain Health Project Management Office to test the effectiveness and safety of at least two pharmacotherapeutic drug candidates for the treatment of PTSD in U.S. military active duty personnel and veterans.
The RPA is part of the Medical Technology Enterprise Consortium (MTEC), and 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 and U.S. Army.
The adaptive platform trial design aims to provide increased efficiency and a streamlined development process for the clinical program. The trial design facilitates evaluating multiple experimental treatment options simultaneously, adding new treatments over time, terminating ineffective treatments and graduating promising treatments to the next stage of development.
The PPD neuroscience clinical and medical experts who will be responsible for the studies are former VA attending psychiatrists and physicians who have treated PTSD in active-duty service members and veterans. Also, the leader of PPD’s government and public health services team who oversees the company’s team of experts focused on this illness is a retired Army veteran who has direct experience with those who suffer from PTSD.
PTSD is a mental health condition that affects about 8 million American adults during a given year. The number of veterans suffering from PTSD varies by service era, but up to 30% of war veterans have had PTSD in their lifetimes, according to the VA’s National Center for PTSD. Currently, there are only two drugs approved by the FDA to treat PTSD, both of which were introduced nearly two decades ago.
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