DoD Peer Reviewed Orthopaedic Clinical Trial Award
The PRORP Clinical Trial Award supports 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. The clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. All applications are required to articulate the relevance of the proposed project to military and/or Veteran populations affected by orthopaedic injury. Collaboration with military researchers and clinicians is encouraged, and studies that include active duty military or Veteran participants as all or a portion of the study population will be considered. Proposed projects may range from small proof-of-concept trials to demonstrate feasibility or inform the design of more advanced trials (i.e., pilot, first in human, or Phase 0), through large-scale trials, to determine efficacy in relevant patient populations. Proof-of-concept trials should not request the maximum funding amount allowed under this Program Announcement/Funding Opportunity. All funding amounts requested should be well-justified and appropriate to the scope of work proposed. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. 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. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. 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. For more information on how to distinguish clinical research from clinical trials, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required and must be submitted to the FDA within 6 months of the award date. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA within 6 months of the award date, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA prior to the application submission deadline, or if documented status of the IND or IDE has not been obtained within 6 months of the award date. The following are important aspects of submission for the Clinical Trial Award: â₏¢ The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies. â₏¢ The proposed intervention to be tested should offer significant potential impact for military personnel with combat-related orthopaedic injuries or non-battle orthopaedic injuries that impact unit readiness and return-to-duty/work. â₏¢ Inclusion of preliminary data relevant to the proposed research project is required. â₏¢ The proposed research project must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. â₏¢ The application should describe the planned indication for the product label, if appropriate, and include an outline of the development plan required to support that indication. â₏¢ The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The PI should discuss how accrual goals will be achieved and how standards of care may impact the study population. â₏¢ The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate. The quality of the product should be commensurate with FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices). â₏¢ The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. â₏¢ The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. â₏¢ The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. â₏¢ The application should include a clearly articulated safety management plan, outlining how safety pharmacovigilance will be conducted, as applicable. â₏¢ The application should include a clearly articulated clinical monitoring plan, outlining how the study will be monitored for GCP compliance. â₏¢ The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other Federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. â₏¢ The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the PRORP Clinical Trial Award. â₏¢ The application should clearly demonstrate strong institutional support (refer to Section II.C., Full Application Submission Content, Supporting Documentation). â₏¢ The application should acknowledge the commitment to filing the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
