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Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Orthopaedic Research Program (PRORP) -- Clinical Trial Award
The FY20 PRORP CTA is intended to support the rapid implementation of clinical trials with the potential to have a major impact on 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 FY20 PRORP CTA differs from the FY20 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, 2020
• Application Submission Deadline: September 10, 2020
Areas of Interest
An estimated 3,700 civilian amputations occur annually as a result of traumatic injury. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Joint Theater Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (during training, leisure activities, resultant from old injuries, etc.) present one of the greatest threats to the readiness of our Service members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and effects military readiness. The PRORP is interested in supporting research that will have an impact on the lives of all individuals that have sustained a major musculoskeletal injury.
All applications submitted to this Program Announcement must address one of the following FY20 PRORP CTA Focus Areas. Selection of the appropriate Focus Area is the responsibility of the applicant. Studies that propose nominal or iterative advancements are not encouraged.
1. Limb Stabilization and Protection: Clinical assessment of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
2. Retention Strategies: 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. Point of Injury: Battlefield-feasible strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on duty and stay on mission without the need for immediate evacuation.
b. Return to Duty: Strategies that can be utilized along the continuum of care to allow an injured Service member to return to duty without separation from Service.
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 anterior cruciate ligament (ACL) or shoulder instability 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 and/or local antibiotic delivery are encouraged.
Independent investigators at all academic levels (or equivalent) may be named by the organization as the PI on the application.
The anticipated total costs budgeted for the entire period of performance for an FY20 PRORP CTA will not exceed $2.25M (Funding Level 1) or $2.75M (Funding Level 2). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.