Peer Reviewed Orthopaedic Clinical Translational Research Award

Description

The FY17 PRORP Clinical Translational Research Award 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 include translational research that evaluates the effectiveness of healthcare practices and/or interventions in neuromusculoskeletal injuries rehabilitation. Projects should demonstrate potential to impact the standard of care, as well as contribute to evidence-based guidelines for the evaluation and care of military or Veteran patients with orthopaedic injuries including, but not limited to, amputation and/or limb salvage. One goal is to better understand and optimize the experiences, health, functional abilities, and quality of life of individuals who receive treatment for traumatic orthopaedic injuries. 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. Proposed projects should be designed to provide information about the impact, advantages, disadvantages, and risks of specific healthcare practices and interventions. To meet the intent of the award mechanism, applications must specifically address one primary FY17 PRORP Focus Areas listed in Section II.A.1, above. 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. Small pilot clinical trials with human subjects are also allowable. 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 research. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Note that purely retrospective or database- related research is not allowed under this funding opportunity. The anticipated total costs budgeted for the entire period of performance for an FY17 PRORP Clinical Translational Research Award will not exceed $2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. 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 FY17 PRORP Applied Research Award (Funding Opportunity Number: W81XWH-17-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 address how the proposed research outcomes will provide new paradigms for or novel insights into the rehabilitation of Service members and/or Veterans who have sustained orthopaedic injuries are strongly encouraged. 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. The following are important aspects of submission for the Clinical Translational Research Award: • Inclusion of preliminary data relevant to the proposed clinical research is required. • The proposed clinical research 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, and include an outline of the development plan required to support that indication. • If applicable, 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. • If applicable, the application should demonstrate access to resources, including but not limited to, patient records, controlled study materials, and/or databases for the proposed clinical research. • 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 U.S. Food and Drug Administration (FDA) manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practices [GMPs]). • If applicable, 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 application should demonstrate that the study team has experience interacting with the FDA, to include previous FDA submissions, if applicable. • The proposed study 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 Code of Federal Regulations, Title 21, Part 11 (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. • If applicable, 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 research, and coordinate participant accrual. • 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 protocol. If applicable, refer to the General Application Instructions, Appendix 6, for more information on study reporting authorities and responsibilities of the research monitor. • The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical phase and/or delivery to the market after the successful completion of the FY17 PRORP Clinical Translational Research Award (see Section II.D.2.b.ii, Full Application Submission Components, Attachment 10: Transition Plan). • 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 that involve clinical trials 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. Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in Landis, S.C., et al. A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (http://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All 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. Orga

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