Peer Reviewed Orthopaedic Clinical Trial Award

Description

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. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. 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. 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 FY17 PRORP Clinical Trial Award. 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 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. 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. The following are important aspects of submission for the Clinical Trial Award: • Inclusion of preliminary data relevant to the proposed clinical trial is required. • The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies. • 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. • 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. • 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. • 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. • 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). • The application should demonstrate the study team has experience interacting with the FDA, to include previous FDA submissions, if applicable. • The proposed clinical trial design should include clearly defined and appropriate endpoints, and follow Good Clinical Practice (GCP) guidelines. • 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. • 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. • The application should include a clearly articulated safety management plan outlining how safety and pharmacovigilance will be conducted, as applicable. • The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance. • 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. • 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 FY17 PRORP Clinical Trial Award. • The application should clearly demonstrate strong institutional support (refer to Section II.D.2.b.ii, Full Application Submission Components, Attachment 2: Supporting Documentation). • 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 the multi-institutional structure governing the research protocol(s) should be outlined in the Attachment 9: Study Personnel and Organization. The lead organization responsible for developing the master protocol and master consent form should be identified, and should be the single point of contact for regulatory submissions and requirements. A single IRB or Ethics Committee (EC) pathway is strongly recommended whenever possible. The master protocol and consent form must be reviewed by the Human Research Protection Office (HRPO) prior to distribution to the additional sites for IRB/EC review. 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. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All Department of Defense (DoD)-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO) prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. Organizations are encouraged to consider use of site personnel familiar with local/host nation regulatory review requirements. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application. Submission to HRPO of protocols covering more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol as DoD-supported research and may include extensive modifications to meet DoD human subjects protection requirements. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. If the

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