OpportunityTitle: DOD Military Burn - Clinical Translation Research Award
Description: The MBRP Clinical Translational Research Award (CTRA) is intended to support clinical 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. Burns have comprised some 5%-20% of the casualties sustained in post-World War II conflicts.1 Potential future conflicts may cause a rise in the number of burn injuries sustained by Service members and the general public should those conflicts occur in rural areas, austere combat zones, and in mass casualty events, whereby medical resources are limited and/or access to medical care is delayed for hours, days, or weeks. In order to prepare the military and the Nation for such potential future conflicts, the FY19/20 MBRP is soliciting research to provide burn care solutions closer to the point of injury for the pre-hospital setting and for a prolonged field care scenario. The North Atlantic Treaty Organization (NATO) defines prolonged field care (PFC) as field trauma care extended beyond doctrinal timelines until the patient can be transported from the point of injury to an appropriate level of care. PFC has been identified as a high priority capability gap across the Army and other Services. Additional information regarding PFC can be found in the following articles, Prolonged Field Care: Beyond the &#8216;Golden Hour&#8217;2 and Prolonged Field Care the New Normal says Army, MRMC Brass.3 Although encouraged, applications submitted to the FY19/20 MBRP CTRA are not required to address PFC. However, the proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. Funding from this award mechanism must support clinical research involving human subjects; animal research is not allowed under this funding opportunity. Principal Investigators (PIs) seeking funding for a preclinical research project should consider the FY19/20 MBRP Idea Development Award Program Announcement, if appropriate. The anticipated total costs budgeted for the entire period of performance for an FY19/20 MBRP CTRA will not exceed $1.55M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $4.65M of the combined FY19 MBRP appropriation to fund approximately three (3) FY19/20 MBRP CTRA applications. In addition, up to $4.65M of the FY20 MBRP appropriation may be available to fund an additional three (3) FY19/20 MBRP CTRA applications, if appropriated. 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 funding opportunity will be funded with FY19 and FY20 MBRP funds, which must be obligated by September 30, 2020, and September 30, 2021, respectively. Awards will be made no later than September 30, 2021. For additional information, refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a &#8220;thing of value&#8221; to a &#8220;state, local government,&#8221; or &#8220;other recipient&#8221; 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. If &#8220;no substantial involvement&#8221; 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 proposed research must address one of the FY19/20 MBRP CTRA Focus Areas. 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. New FY19 definition: A clinical trial is 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. These outcomes represent a direct effect on the subject of that intervention or interaction. Funded 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 Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). The term &#8220;human subjects&#8221; is used in this Program Announcement to refer to individuals who will be recruited for or who will participate in the proposed clinical study. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. The following are important aspects of the MBRP CTRA: &#8226; Inclusion of preliminary data relevant to the proposed clinical research is required. &#8226; The proposed clinical research study outcomes should provide burn care solutions closer to the point of injury, and/or benefit the burn casualty in a prolonged field care scenario. &#8226; 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. &#8226; 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. &#8226; The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. &#8226; 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. &#8226; 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 FY19/20 MBRP CTRA. If the application proposes a clinical trial that involves 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 and 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) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/ap provalapplications/investigationalnewdrugindapplication/default.htm. If the investigational product is a 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 trial. Refer to Attachment 7, Regulatory Strategy, for additional details on documentation of FDA applications. The Government reserves the right to withdraw funding if an IND or IDE application is necessary but has not been submitted within 12 months of the award date. 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 Institutional Review Board (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. 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 as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) &#8220;Funding Opportunities &amp; Forms&#8221; web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. If the IRB determines that a trial presents greater than minimal risk to human subjects, the 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 1, for more information on study reporting authorities and responsibilities of the research monitor. 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 Attachment 8: 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 EC pathway is strongly recommended whenever possible. The master protocol and consent form must be reviewed by the 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. PIs are encouraged to integrate and/or align their research projects with DoD and/or Department of Veterans Affairs (VA) research laboratories and programs. Collaboration with the DoD or VA is also encouraged (Appendix 2). Potential for future product development partnerships with the U.S. Army Medical Materiel Development Activity (https://www.usammda.army.mil/) may be available depending on the maturity and impact of the product on the military. Recruitment Milestones: For research involving human subject enrollment, the application must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work. Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Use of DoD or VA Resources: If the proposed research involves access to active duty military patient populations and/or DoD resources or databases, the application must describe the access at the time of submission and a plan for maintaining access as needed throughout the proposed research. Access to target active duty military patient population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research involves access to VA patient populations, VA study resources and databases, and/or VA research space and equipment, VA PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&amp;D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the funds, the application should include a letter from the VA ACOS/R&amp;D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone: 301-682-5507 &lt;br/&gt;Email:  help@eBRAP.org