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#### W81XWH-22-PRORP-CTRA

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Joint Theatre Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., during training, leisure activities, resultant from old injuries, etc.) present one of the greatest threats to the readiness of our Service Members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and affects military readiness. The PRORP is interested in supporting research that will have an impact on the lives of all individuals that have sustained a major musculoskeletal injury.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, Veterans and all patients with orthopaedic injuries.• One goal of the FY22 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military patients. The health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered.• 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.The FY22 PRORP CTRA differs from the FY22 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects that may or may not include a clinical trial, whereas the CTA is restricted to clinical trials only.Applications to the FY22 PRORP Clinical Translational Research Award mechanism must support clinical research and may not be used for animal research. Animal research is not allowed under this funding opportunity. Investigators seeking support to conduct studies involving animal research should consider applying to the FY22 PRORP Applied Research Award (funding opportunity number W81XWH-22-PRORP-ARA [Applied Research Award]) mechanism, which can be accessed at https://cdmrp.army.mil/funding/.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 allowable.Key aspects of the PRORP Clinical Translational Research Award Mechanism:• Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical study is required.• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical study appropriate to the objectives of the study.• Intervention Availability, as applicable: The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate and applicable, for the proposed duration of the study.• Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical research, including appropriate statistical analysis, knowledge of Food and Drug Administration (FDA) processes (if applicable), and data management. Applications that include clinical trials should identify 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 study, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, are fulfilled.• Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study and a data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the study must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de- identified specimens or data, if these sources are publicly available.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Funded clinical trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. Funded clinical trials are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section B, for further details.If the proposed research includes the use of a drug that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the FDA within 12 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 application) and indication to be tested in the proposed clinical study. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.If the proposed research includes the use of an investigational device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required, or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA within 12 months of the award date. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical study.If the proposed research includes a clinical trial of an investigational product to be conducted at international sites, an application to the relevant national regulatory agency of each host country must be submitted within 12 months of the award date.The government reserves the right to withdraw funding if an IND or IDE application and/or international regulatory application is necessary but has not been submitted within 12 months of the award date.All applications should 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, but not required. Collaboration with military and VA researchers and/or clinicians is also encouraged.The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY22 PRORP Clinical Translational Research Award will not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately$6.0M to fund approximately four Clinical Translational Research Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.
Categories: Science and Technology and other Research and Development.
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