DoD Military Burn, Clinical Translation Research Award

Description

The MBRP CTRA is intended to support human research projects that are likely to have a major impact on therapy by applying promising and well-founded laboratory, preclinical, or clinical research findings to the care of the burn-injured patient.The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.Inclusion of preliminary data relevant to the proposed clinical research is required.The proposed study must include clinical research, and may include initial proof of concept trials, studies involving use of human anatomical substances, observational studies, and/or involve some retrospective data analysis. Large randomized clinical trials are discouraged.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.Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available Federal website in accordance with Federal requirements described in Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).Funding from this award mechanism must support clinical research involving human subjects; animal research is not allowed under this funding opportunity.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 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 MBRP CTRA 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, 2021. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $7.0M to fund approximately four or five MBRP CTRA 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 FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 2026.The following are important aspects of the MBRP CTRA:• The proposed clinical research study must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.• The proposed clinical research study is expected to begin no later than 12 months after the award date, or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies.• The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study.• 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 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 MBRP CTRA.• Funded studies that contain 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 C, for further details.

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