DoD Orthopaedic Care and Rehabilitation Consortium Award | Apply Online

FAQs: DoD Orthopaedic Care and Rehabilitation Consortium Award (OCRCA) (FY2015)

What is the DoD Orthopaedic Care and Rehabilitation Consortium Award (OCRCA)?

The OCRCA was a FY2015 funding opportunity under the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), within the Congressionally Directed Medical Research Programs (CDMRP) and the Peer Reviewed Orthopaedic Research Program (PRORP). Its purpose was to establish a durable, multi-institution clinical research consortium focused on severe musculoskeletal injuries tied to military combat or combat-related activities, including both acute care outcomes and long-term rehabilitation outcomes.

Is this a standard grant or something else?

It was offered as a cooperative agreement, not a standard grant. This meant the Government planned to stay actively involved in shaping and overseeing the consortium through a Government Steering Committee and ongoing interactions with USAMRMC staff.

What was the main goal of this opportunity?

The main goal was to stand up a lasting clinical research consortium capable of running complex, multi-site clinical studies focused on combat-relevant severe musculoskeletal injuries and improving both early treatment outcomes and long-term functional recovery.

When was the opportunity open and when did it close?

The opportunity was posted on September 1, 2015, closed on December 8, 2015, and was archived on January 7, 2016.

How many awards were expected?

One award was anticipated (ExpectedAwards: 1).

What was the estimated total funding amount?

The estimated total funding was $18,000,000.

Was cost sharing or matching required?

No. The opportunity stated there was no cost sharing or matching requirement.

Who was eligible to apply?

Eligibility was listed as unrestricted, meaning a wide range of entity types could compete, as long as they met the specific consortium structure and Coordinating Center requirements described in the announcement.

What is the required consortium structure?

The award was organized around a single lead entity called the Coordinating Center. The Coordinating Center would submit one application on behalf of the entire consortium and could also serve as a clinical study site.

What is the Coordinating Center expected to do?

The Coordinating Center was expected to function as the hub for governance and operations, including coordinating and standardizing execution across participating sites. It would also manage the consortium operationally and distribute funds to clinical study sites through subawards or other appropriate funding instruments.

Were Military Treatment Facilities (MTFs) required partners?

Yes. The Coordinating Center was required to collaborate with multiple Military Treatment Facilities (MTFs).

Could non-military clinical sites participate?

Yes. Inclusion of non-military clinical study sites was encouraged to broaden enrollment capacity and bring in additional expertise.

What types of organizations were envisioned as consortium partners?

The announcement explicitly envisioned collaborations that could include academia, MTFs, other government agencies, clinical research institutions, industry partners, and nonprofit organizations, organized around shared clinical study priorities and standardized execution across sites.

What kind of research was allowed under this mechanism?

This mechanism was limited strictly to clinical research and clinical trials involving human subjects. Animal studies were not allowed.

How did the opportunity define a clinical trial?

A clinical trial was described as prospective enrollment of human subjects where an intervention is tested and outcomes are measured, such as safety, effectiveness, efficacy, or other exploratory endpoints.

What kinds of interventions could be studied?

Interventions could include devices, drugs, biologics, surgical procedures, rehabilitation modalities, behavioral interventions, or similar approaches.

Were randomized controlled trials required or just encouraged?

Randomized controlled trials were expected to be a major component of the consortium's research activities.

Were smaller or early-stage studies allowed?

Yes. The opportunity allowed smaller randomized studies, pilot trials, and prospective observational studies when needed to establish metrics, demonstrate proof of principle, or generate data to design larger definitive trials later.

What injury area and patient focus was this consortium meant to address?

The consortium was focused on severe musculoskeletal injuries tied to military combat or combat-related activities, with emphasis on both acute care outcomes and long-term functional rehabilitation outcomes.

How important was military relevance in proposed studies?

Military relevance was a central theme. Proposed studies needed to be clearly relevant to military needs, have well-defined objectives, and be designed so results would be interpretable and credible.

What did the program expect regarding study design quality?

The opportunity emphasized practicality and real-world impact, including the need to control for confounding variables so that findings would be credible and interpretable for practice decisions.

What did the program expect regarding patient population and enrollment capacity?

The consortium needed access to patient populations large enough to support robust sample sizes at each participating site, which is essential for multi-site clinical studies intended to change clinical practice.

If non-military patients were included, were there special requirements?

Yes. If a study planned to enroll non-military patients, the applicant had to explain how those participants would simulate or match the target population (service members and/or U.S. veterans) so findings would remain meaningful for combat-relevant injuries and care settings.

Was cost or value analysis part of the research expectations?

Yes. Each project was expected to develop a procurement cost estimate for successful treatments so military and civilian health systems could conduct cost-benefit comparisons versus current practice and identify optimal cost-effective approaches.

What kinds of outputs were expected by the end of the performance period?

The Government anticipated that, by the end of the performance period, the awardee would have created strong, lasting infrastructure capable of continuing clinical studies beyond the initial award. Expected outputs were not limited to publications and included actionable information, practice guidelines, validated techniques, or devices that could change clinical practice or validate existing practice, improving outcomes for injured service members, U.S. veterans, and civilians with similar injury patterns.

How was the Government involved during the project?

Because it was a cooperative agreement, the Government planned active involvement through a Government Steering Committee and ongoing interactions with USAMRMC staff, shaping and overseeing consortium activities.

What made this opportunity distinct from a typical single-site clinical trial award?

The award was designed to establish a multi-institution consortium with a central Coordinating Center, multiple MTF collaborations, standardized execution across sites, and the capacity to conduct multiple complex clinical studies over time rather than a single standalone study.