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#### W81XWH-20-PRORP-CTRA

The PRORP CTRA mechanism was first offered in FY16. Since then, 57 CTRA applications have been received, and 12 have been recommended for funding.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, Veteran, and all patients with orthopaedic injuries.• One goal of the FY20 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 FY20 PRORP CTRA differs from the FY20 PRORP Clinical Trial Award (CTA) in that the CTRA allows for clinical research projects, whereas the CTA is restricted to clinical trials only. Funding from this award mechanism must support clinical research; animal research is not allowed. 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.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. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.If the proposed research includes 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. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (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 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.Recruitment Milestones: Successful applicants will work with CDMRP and USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones.Animal research is not allowed under this funding opportunity. Investigators seeking support to conduct studies involving animal research should consider applying to the FY20 PRORP Applied Research Award (Funding Opportunity Number: W81XWH-20-PRORP-ARA) mechanism, which can be accessed at https://cdmrp.army.mil/funding/.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 following are important aspects of the FY20 PRORP CTRA, as applicable and appropriate for the type of clinical research proposed:• Inclusion of preliminary data relevant to the proposed clinical research is required.• Long-term outcomes of the proposed research 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 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 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 population.• The application should demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. The quality and stability of the product should be documented and commensurate with current FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practice [GMP] guidelines).• The proposed clinical research study design should include clearly defined objectives and appropriate endpoints/outcome measures, and comply with current 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 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. If FDA-regulated, the research 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.• The application should include a clearly articulated safety management plan outlining how safety 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 IRB of record and other Federal agency regulatory approval processes, coordinate activities from all sites participating in the clinical study, 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 phase and/or delivery to the market after the successful completion of the FY20 PRORP CTRA.• The application should clearly demonstrate strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled.• Funded studies that include a clinical trial are required to post a copy of the IRB-approved informed consent form used to enroll subjects on a publicly available Federal website in accordance with Federal requirements described in 32 CFR 219.• Funded studies that include clinical trial 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 C, for further details.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 FY20 PRORP CTRA 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, 2021. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately$6M to fund approximately four CTRA 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 FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 2026.
Categories: Science and Technology and other Research and Development.
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