Congressionally Directed Medical Research Programs (CDMRP) -- Peer Reviewed Orthopaedic Research Program (PRORP) -- Clinical Trial Award

Funding Agency:
Department of Defense

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Joint Theatre Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., 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 affects 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.

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.

Applications to the FY22 PRORP Clinical Trial Award mechanism must support a clinical trial and may not be used for animal or preclinical studies. The FY22 PRORP CTA differs from the FY22 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only.

Deadlines:

• Required Pre-Application Deadline:  June 16, 2022

• Application Submission Deadline:  September 13, 2022

Agency Website

Areas of Interest

In September 2021, the PRORP hosted a stakeholders meeting to identify critical knowledge and capability gaps in orthopaedic research and care. Representatives from non-profit organizations, academia, industry, government institutions, and the public shared broad perspectives on potential barriers in research and patient outcomes, key knowledge and scientific gaps, and potential approaches for addressing orthopaedic needs. Resources shared during the meeting and outcomes of the effort can be found on the CDMRP website (https://cdmrp.army.mil/ prorp/default). The FY22 PRORP Focus Areas incorporate several of the stakeholder-identified gaps.

Applications submitted to this program announcement must address one of the following FY22 PRORP Applied Research Award 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 or avoid reinjury 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.

  • 2a. 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.
  • 2b. 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 practice.

  • 3a. Soft Tissue Trauma: Strategies for musculoskeletal extremity soft tissue trauma treatments for shoulder, knee, or chronic ankle instability and sequela only, to optimize return to duty, work, or reintegration.
  • 3b. 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.

Eligibility Requirements

Independent investigators at all academic levels (or equivalent) may be named by organizations as the PI on the application. There is no limitation 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.

Amount

$3,000,000

Amount Description

The anticipated total costs budgeted for the entire period of performance for an FY22 PRORP Clinical Trial Award will not exceed $2.5M (Research Level 1) or $3.0M (Research Level 2). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Funding Type

Award
Grant

Eligibility

Faculty
Junior Faculty
Medical Fellow/Resident
Post Doctoral Fellows

Category

Engineering and Physical Sciences
Medical
Medical - Clinical Science

External Deadline

June 16, 2022