PTSD Adaptive Platform Trial Request for Information
In September 2018, Cohen Veterans Bioscience, a translational non-profit research organization dedicated to fast-tracking personalized diagnostics and therapeutics for brain health, was granted a research award by Advanced Technology International (MTEC Consortium Manager) on behalf of the U.S. Army Medical Research and Materiel Command (MRMC). The grant is for a 3.5-year clinical trial to test the efficacy and safety of pharmaco-therapeutics for post-traumatic stress disorder (PTSD) via a well-powered adaptive platform trial (APT). Cohen Veterans Bioscience (CVB) will lead this program and serve as the Clinical Coordinating Center (CCC), establishing a clinical trial infrastructure operating within the trial’s governance structure. A government Joint Steering Committee (JSC) is a part of the governance structure and includes representatives from the Veterans Health Administration (VA), the National Institute of Mental Health, National Institute of Alcohol Abuse and Alcoholism, the FDA, and the Defense Health Agency’s Psychological Health Center of Excellence.
This Phase 2 adaptive design clinical trial is scheduled to start in the spring of 2020 and during the period of performance, at least two active drugs (pending selection) will be tested. Biological measurements will be incorporated to support a precision medicine approach to PTSD treatment. A goal of this trial is to identify a drug to move forward for Phase 3 testing starting in 2022 and ultimately lead to an alternative FDA-approved drug for the treatment of PTSD.
The purpose of the Request for Information is to identify companies that have compounds in development that may be suitable candidates for inclusion in the PTSD Adaptive Platform Trial program at launch and who are interested to participate in the program.
If an investigational drug is part of the PTSD Adaptive Platform Trial program at launch (defined as being listed in one of the original drug treatment arms), study-related costs will be paid for, per the negotiated agreement. These costs may include IRB and study-related regulatory submissions, CROs, investigator fees, data management and statistical analyses.
While not guaranteed at this time, if an investigational drug is included as an additional arm after the PTSD Adaptive Platform Trial has launched, there is a possibility that an appropriate proportion of the incremental trial costs may be paid for, in negotiation with the Company.
Scope & Timelines
Companies identified as “meeting criteria” per this RFI will be contacted to discuss program goals, study design, benefits of participation in the program, and terms & conditions of participation.
Eligible companies and compounds will enter a decision process led by CVB to select the initial drugs to be tested in the study as well as those to be considered for queue in the platform. Final decisions will be made by the Department of Defense. Once selected, CVB and Company will engage in contract negotiations to finalize study agreements.
Please visit https://apt.cohenveteransbioscience.org for more information.