DoD Orthopaedic Care and Rehabilitation Consortium Award
The PRORP OCRCA mechanism is being offered for the first time in FY15. The PRORP OCRCA is intended to support the establishment of a Consortium that consists of multiple organizations and individuals collaboratively working on clinical studies that are focused on improving both acute care treatment outcomes and functional, long-term rehabilitation outcomes of severe musculoskeletal injuries commonly associated with military combat or combat-related activities. The Consortium will consist of a single Coordinating Center in collaboration with multiple military treatment facilities (MTFs) (required) and non-military Clinical Study Sites (encouraged). The Government anticipates that applicants will assemble an expert team from multiple institutions, including, but not limited to, academia, MTFs, other Government agencies, clinical research institutions, industry partners, and not-for-profit enterprises to satisfy the objectives of this Program Announcement/Funding Opportunity. It is expected that relevant clinical outcomes will require longitudinal evaluations to optimize recovery and restoration of function. At the end of the performance period, it is anticipated that the awardee will establish a strong infrastructure for continuing clinical studies on combat-relevant musculoskeletal injuries and produce products (information, practice guidelines, validated techniques, or devices) that result in changes to, or validation of, current clinical practices that lead to better outcomes for injured Service members, U.S. Veterans, and civilians. All projects should develop a procurement cost estimate for successful treatments so that the military and civilian medical community can conduct a cost-benefit analysis with current practice alternatives, as well as distinguish the optimal cost-effective treatments. Projects must be relevant to the military, have well-defined objectives, control for confounding variables, have a patient population that will allow for an appropriately robust sample size at each Site, be of high quality, and be capable of producing results that are likely to change practice. Studies involving non-military patient populations must describe how they simulate the targeted population (i.e., Armed Forces and/or the U.S. Veteran population). While large, randomized, controlled clinical studies are expected to be part of this multi-institutional Consortium effort, small randomized or pilot clinical trials and observational prospective studies to develop metrics or provide proof of principle to inform future clinical studies are also appropriate. All projects shall be limited to clinical research and clinical trials. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term â₏œhuman subjectsâ₏ is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. Clinical research encompasses studies in which individuals are observed or those where certain outcomes are measured. For more information on how to distinguish clinical research from clinical trials, see the Human Subject Resource Document at https://ebrap.org/eBRAP/public/Program.htm. Animal studies are excluded from consideration. The Coordinating Center must apply to this Program Announcement/Funding Opportunity through a single application, and may also serve as a Study Site. The PRORP OCRCA resulting from this Program Announcement/Funding Opportunity will be issued as a cooperative agreement between the recipient (Coordinating Center) and the Government. The Government will have substantial involvement in the Consortium through a Government Steering Committee (GSC) and U.S. Army Medical Research and Materiel Command (USAMRMC) staff interactions with the Consortium. The GSC will review research priorities and make recommendations to the Grants Officerâ₏™s Representative (GOR) for the GORâ₏™s consideration, with ultimate approval decisions made by the USAMRAA Grants Officer (GO). Award funds will be used to support the Coordinating Centerâ₏™s efforts as well as Consortium-associated studies at the Clinical Study Sites. The Coordinating Center will provide management and funding for the Clinical Study Sites through the appropriate subaward or other instrument.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
