DoD PH/TBI Investigational Treatments for TBI and PTSD Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD PH/TBI Investigational Treatments for TBI and PTSD Clinical Trial Award (ITTPCTA), Funding Opportunity Number W81XWH-14-PHTBIRP-ITTPCTA, was a Fiscal Year 2014 grant and cooperative agreement opportunity run by the Department of the Army through USAMRAA under the broader Psychological Health/Traumatic Brain Injury Research Program (PH/TBIRP). Its central purpose was to carry out Section 704 of the National Defense Authorization Act for Fiscal Year 2014 by launching a pilot effort and formalizing a process for running randomized, placebo-controlled clinical trials that test investigational treatments for traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). A notable emphasis of the program was that these trials were intended to occur in health care facilities other than military treatment facilities, focusing on care environments outside the standard military hospital system. The scope also explicitly included investigational diagnostic testing, meaning applicants could propose trials evaluating diagnostic approaches as well as therapeutic interventions, as long as they fit the overall requirement for rigorous randomized, placebo-controlled clinical testing.

The opportunity was categorized as discretionary funding in the science and technology/research and development domain, and it supported awards through either a grant or a cooperative agreement mechanism. The inclusion of cooperative agreements signaled that the government anticipated substantial involvement in the project beyond routine grant administration, which is common for complex clinical trial programs where coordination, oversight, and standardized processes can be important. The CFDA listing associated with the announcement was 12.420, Military Medical Research and Development, reflecting its defense medical research focus and the intent to generate evidence relevant to service members and the military health enterprise.

Funding levels were limited and competitive. The announcement projected an expected two awards with an estimated total funding of $5,000,000. The posting date and creation date were both September 19, 2014, and the closing date was January 23, 2015, with the record later archived on February 22, 2015. There was no cost sharing or matching requirement, reducing the burden on applicants to bring non-federal funds to the table and making the program more accessible to a range of organizations that could carry out clinical research.

Eligibility was described as unrestricted, meaning it was open to essentially any type of applicant entity (for example, academic institutions, nonprofits, for-profits, hospitals, and other research organizations), subject to any additional clarifications that would have been contained in the full text of the announcement. In practical terms, this broad eligibility aligned with the program goal of conducting trials in non-military facilities, since many capable trial sites and coordinating centers for TBI and PTSD research reside in civilian academic medical centers, community hospitals, and private research networks.

For applicants needing help accessing the full announcement or navigating the electronic submission and management environment, the opportunity directed users to the CDMRP eBRAP Help Desk, providing both a phone number (301-682-5507) and an email address (help@eBRAP.org). This is consistent with CDMRP-managed programs where eBRAP is commonly used for pre-application steps and tracking, even when final submissions may occur through other federal portals depending on the specific solicitation requirements.

In short, this FY14 ITTPCTA was designed to push high-quality, randomized, placebo-controlled clinical evidence generation for investigational TBI and PTSD treatments and diagnostics, specifically geared toward Armed Forces populations and intentionally structured to be executed in non-military health care settings, with a small number of relatively sizable awards under DoD medical research oversight.

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Previous opportunity: DoD PH/TBI Community Partners in Mental Health Research Award

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