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Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Orthopaedic Research Program (PRORP) -- Clinical Trial Award
The PRORP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return to duty/work rates. Applicants are encouraged to address how the proposed research will support patient care closer to the point of injury and/or allow patients to more quickly return to duty/work. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0), to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.
The FY21 PRORP CTA differs from the FY21 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only.
• Required Pre-Application Deadline: May 27, 2021
• Application Submission Deadline: September 10, 2021
Areas of Interest
All applications submitted to this program announcement must address one of the following FY21 PRORP CTA Focus Areas. Selection of the appropriate Focus Area is the responsibility of the applicant.
1. Limb Stabilization and Protection: Clinical evaluation of rapid limb stabilization and novel wound protectants for severely or critically wounded limbs to enable prolonged care and eventual transport to the point of definitive treatment.
2. Retention Strategies: Optimization and/or validation of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries. Biomarker studies are excluded. The current standard of care must be noted. The rehabilitation strategy to be used in the proposed study must be specified, as applicable. a. Battlefield Care: Strategies that can be utilized at or near the point of injury to allow an injured Service Member to remain on the battlefield or on mission without the need for evacuation. Treatment strategies that allow return to mission effectiveness within 30 days will be considered. b. Return to Duty: Treatment strategies that can be utilized along the continuum of care and enable return to duty of the Service Member within 1 year of injury.
3. Translation of Early Findings: Translation of early research findings in the orthopaedic surgical care topic areas listed below to move the research toward clinical trials and clinical practice. a. Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for shoulder, knee, or chronic ankle instability and sequela only, to optimize return to duty, work, or reintegration. b. Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication). Alternatives to systemic antibiotic delivery are encouraged. Novel approaches that improve the current standard of treatment to prevent fracture-related infections are encouraged.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application. There are no limitations on the number of applications for which an investigator may be named as a PI. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organization.
The anticipated total costs budgeted for the entire period of performance for an FY21 PRORP Clinical Trial Award will not exceed $2.25M (Research Level 1) or $2.75M (Research Level 2). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.