DoD Peer Reviewed Orthopaedic, Clinical Trial Award

Description

The 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. 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. 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. The FY18 PRORP CTA differs from the FY18 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Funding from this CTA award mechanism must support a clinical trial and may not be used for preclinical research studies. Proposed projects may range from small proof-of-concept trials (i.e., pilot, first in human, or Phase 0) to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. 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 safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human 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 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 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, or if documented status of the IND or IDE has not been obtained within 12 months of the award date. Animal research is not allowed under the FY18 PRORP CTA. Principal Investigators (PIs) seeking funding for a preclinical research project 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. Collaboration with military and VA researchers and/or clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged.

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