DOD Deployment Related Medical Research Program

The summary for the DOD Deployment Related Medical Research Program grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

DOD Deployment Related Medical Research Program: The DRMRP Clinical Trial Award mechanism is being offered for the first time in FY08. This award supports rapid implementation of clinical trials with the potential to have a significant impact on a disease or condition addressed in one of the FY08 DRMRP topic areas. All proposed clinical trials must be responsive to the healthcare needs of deployed members of the Armed Forces and may address prevention, detection, diagnosis, treatment, and/or quality of life. The clinical trial may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), cognitive/behavioral interventions, devices, clinical guidance, and/or emerging approaches and technologies. Funding from this award mechanism cannot be used for preclinical research studies. PIs seeking funding for a preclinical research project should apply to the Advanced Technology/Therapeutic Development Award mechanism. Each proposal should contain only one clinical trial with a distinct study design. Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications should be submitted or approved prior to proposal submission. The Government reserves the right to withdraw funding if IND/IDE approval is not received within 6 months of the award date. Principal Investigators (PIs) must clearly specify in the Clinical Protocol (main body of the proposal) which type of clinical trial is being proposed: Phase 0, Phase I, Phase II, or Phase III or a combination. For descriptions of each type of clinical trial, please refer to www.fda.gov/cder/guidance/6384dft.htm and http://www.clinicaltrials.gov. Refer to the Application Instructions, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. The proposed clinical trial is expected to begin within 12 months of the award date. The following are important aspects of the Clinical Trial Award submission: . Demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study. . Describe clearly defined and appropriate endpoints for the proposed clinical trial. . Clearly articulate the statistical analysis plan. . Discuss the potential impact of the study results for patients with the specified disease/condition. . Include a named study coordinator(s) who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board, and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. . Demonstrate institutional support. Military relevance is a key feature of this award. Therefore, PIs are strongly encouraged to collaborate and integrate their projects with military and/or Veterans Affairs (VA) research laboratories and programs. Each PI must provide a transition plan (including funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the military market after the successful completion of this DRMRP award. Proposals must include preliminary and/or published data relevant to the topic area and the proposed project. See the Program Announcement for the full Funding Opportunity Description.