DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award

Description

The PRORP CTRA mechanism was first offered in FY16. Since then, 44 CTRA applications have been received, and 8 have been recommended for funding. The PRORP CTRA is intended to support high-impact and/or new/emerging clinical research that may or may not be ready for a full-scale randomized controlled clinical trial. Projects should demonstrate potential to impact the standard of care, both immediate and long-term, as well as contribute to evidence-based guidelines for the evaluation and care of military, Veteran, and all patients with orthopaedic injuries.  One goal of the FY19 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military patients closer to the point of injury and in a delayed evacuation scenario. The health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered.  Another goal is to identify the most effective diagnosis, treatment, rehabilitation, and prevention options available to support critical decision-making for patients, clinicians, other caregivers, and policymakers. The FY19 PRORP CTRA differs from the FY19 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Funding from this award mechanism must support clinical research; animal research is not allowed. The proposed studies may be interventional and may involve some retrospective data analysis. Note that purely retrospective or database-related research is not allowed under this funding opportunity. Small pilot clinical trials with human subjects are also allowable. New FY19 definition: A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. If the proposed research includes 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. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm. If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required, or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA within 12 months of the award date. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. Refer to Attachment 8: Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted within 12 months of the award date. Recruitment Milestones: The application must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Animal research is not allowed under this funding opportunity. Investigators seeking support to conduct studies involving animal research should consider applying to the FY19 PRORP Applied Research Award (Funding Opportunity Number: W81XWH-19-PRORP-ARA) mechanism, which can be accessed at https://cdmrp.army.mil/funding/. All applications are required to articulate the relevance of the proposed project to military and/or Veteran populations affected by orthopaedic injury. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged. Collaboration with military and VA researchers and/or clinicians is also encouraged.

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