DoD FY15 Reconstructive Transplant Research (RTR) Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD FY15 Reconstructive Transplant Research (RTR) Clinical Trial Award (Funding Opportunity Number W81XWH-15-RTR-CTA) is a U.S. Department of Defense funding opportunity designed specifically to support human clinical trials in reconstructive transplantation research, with an emphasis on outcomes that matter to injured Service members and Veterans. The solicitation was issued by the U.S. Army Medical Research Acquisition Activity (USAMRAA) on behalf of the Defense Health Agency, Research, Development, and Acquisition (DHA RDA) Directorate, which manages Defense Health Program research dollars under the Research, Development, Test, and Evaluation appropriation. While the money originates within DoD health research priorities, the program and awards are administered through the Congressionally Directed Medical Research Programs (CDMRP), with strategic guidance from Joint Program Committee 8 (Clinical and Rehabilitative Medicine Research Program).

This award mechanism was offered for the first time in FY15 and is explicitly intended to fund clinical trials that could meaningfully improve function, wellness, and overall quality of life, not only for patients but also for caregivers and families, and potentially the broader public. The program frames its mission around reconstructive transplantation and vascularized composite allotransplantation (VCA) related challenges, and applicants are required to align their proposed work with at least one of the program’s stated Focus Areas. Those Focus Areas include immune system regulation (for example, improving immunosuppression strategies or immune tolerance approaches), improved access to reconstructive transplantation (which can include removing logistical, clinical, or systems barriers), reconstructive transplantation rehabilitation (optimizing recovery and functional outcomes), graft surveillance and clinical monitoring (methods to detect rejection, complications, and performance issues earlier and more reliably), and psychosocial issues associated with VCA (mental health, adjustment, adherence, identity, social reintegration, and related caregiver/family impacts).

A central requirement of the RTR Clinical Trial Award is that funds must be used to conduct a clinical trial, and not preclinical or purely laboratory research. The announcement uses a standard definition of a clinical trial: the prospective enrollment (accrual) of human subjects in which an intervention is tested for a measurable outcome. The intervention can be broad, including devices, drugs, biologics, surgical procedures, rehabilitation modalities, behavioral interventions, or other approaches, but it must be evaluated through outcomes that speak to exploratory findings, safety, effectiveness, and/or efficacy. In other words, the research has to involve direct interaction with human participants and assess the real-world effects of the intervention on those participants. Investigators who only have preclinical aims are directed to consider other RTR funding mechanisms rather than this one.

From an administrative and funding standpoint, the opportunity was categorized as discretionary and could be made as a cooperative agreement or grant, under the science and technology/research and development activity area. The listing is associated with CFDA 12.420 (Military Medical Research and Development). The total estimated funding for the competition was $6,000,000, with an expectation of making about two awards, and it did not require cost sharing or matching. Eligibility was described as unrestricted, meaning it was broadly open to a wide range of applicant organization types, subject to any additional eligibility details contained in the full announcement.

Key dates included a posted and creation date of July 23, 2015, and an application closing date of December 1, 2015 (with an archive date of December 31, 2015). For applicant support, CDMRP provided a help desk contact (help@cdmrp.org and 301-682-5507) for issues accessing the full announcement.

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