OpportunityTitle: Peer Reviewed Orthopaedic Clinical Trial Award
Description: The PRORP Clinical Trial Award mechanism was first offered in FY09. Since then, 191 Clinical Trial Award applications have been received, and 18 have been recommended for funding. 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. 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 safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term &#8220;human subjects&#8221; 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, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. 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. 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. All funding amounts requested should be well-justified and appropriate to the scope of work proposed. 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 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. This award is intended to support clinical trial studies that have potential to develop novel interventions in either surgical care or rehabilitation. Animal research is not allowed under the FY16 PRORP Clinical Trial Award. The following are important aspects of submission for the Clinical Trial Award: &#61623; The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies. &#61623; The proposed intervention to be tested should offer significant potential impact for military personnel and Veterans with combat-related orthopaedic injuries or non-battle orthopaedic injuries that impact unit readiness and return-to-duty/work. &#61623; Inclusion of preliminary data relevant to the proposed clinical trial is required. &#61623; The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature. &#61623; The application should describe the planned indication for the product label, if appropriate. Likewise, it should include an outline of the development plan and regulatory strategy required to support that indication. &#61623; The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. The applicant should discuss how accrual goals will be achieved and how standards of care may impact the study enrollment. &#61623; 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). &#61623; The application should demonstrate the study team has experience interacting with the FDA, to include previous FDA submissions, if applicable. &#61623; The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. &#61623; 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. &#61623; 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. For FDA-regulated studies, compliance with 21 CFR 11 is required. &#61623; The application should include a clearly articulated safety management plan outlining how safety and pharmacovigilance will be conducted, as applicable. &#61623; The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance. &#61623; 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. &#61623; For studies determined to be greater than minimal risk to human subjects by the local IRB of record, the Department of Defense (DoD) requires an independent research monitor with expertise consistent with the nature of risk(s) identified within the research project. If applicable, refer to the General Application Instructions, Appendix 6, for more information on study reporting authorities and responsibilities of the research monitor. &#61623; 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 FY16 PRORP CTA. &#61623; The application should clearly demonstrate strong institutional support (refer to Section II.C., Full Application Submission Content, Supporting Documentation). &#61623; Funded studies are required to file the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov. Refer to the General Application Instructions, Appendix 6, Section C, for further details. Multi-Institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for communication and data transfer among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials.
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