DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award

Description

The anticipated total costs budgeted for the entire period of performance for an FY18 PRORP CTRA will not exceed $2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. 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 or Veteran patients with orthopaedic injuries. One goal is to translate current and emerging techniques and interventions into the clinical space to better serve military patients more closely to the point of injury and in the PFC environment. The health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered. Another goal of the FY18 PRORP CTRA 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. Applications proposing sports injury research will not meet the intent of the award mechanism and will not be considered for funding unless the proposed research involves sports injuries that are related to a combat injury. To meet the intent of the award mechanism, applications must specifically address one primary FY18 PRORP CTRA Focus Area listed in Section II.A.2, above. The FY18 PRORP CTRA differs from the FY18 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 studies involving human subjects. 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. A clinical trial is defined as a prospective accrual of patients (human subjects) in whom an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. If the proposed 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. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND) and indication to be tested in the proposed clinical trial. 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 or qualifies for an abbreviated 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 within 6 months of the award date. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/ap provalapplications/investigationalnewdrugindapplication/default.htm. Animal research, to develop or refine new technology or research to establish the efficacy/ effectiveness of diagnostic agents, or otherwise, is not allowed under this funding opportunity. Investigators seeking support to conduct studies involving animal research should consider applying to the FY18 PRORP Applied Research Award (Funding Opportunity Number: W81XWH-18-PRORP-ARA) mechanism, which can be accessed at http://cdmrp.army.mil/funding/default.shtml. 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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