DoD Neurofibromatosis Clinical Trial Award

The summary for the DoD Neurofibromatosis Clinical Trial Award 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 Neurofibromatosis Clinical Trial Award: The NFRP Clinical Trial Award (CTA) mechanism was created in FY99. Since then, 18 Clinical Trial Award proposals have been received, and 3 have been recommended for funding. The NFRP Clinical Trial Award supports clinical research with the potential to have a major impact on the treatment and/or management of neurofibromatosis and/or Schwannomatosis. Funding from this award mechanism cannot be used for preclinical research studies. Clinical Trial Awards will support Phase 0, Phase I, and Phase II clinical trials (please refer to http://www.clinicaltrials.gov and www.fda.gov/cder/guidance/6384dft.htm for descriptions of each type of clinical trial). Applicants must clearly specify in their proposals which type of clinical trial is being proposed: Phase 0, Phase I, or Phase II. Each proposal should contain only one clinical trial with a distinct study design. Clinical trials must begin within 12 months of the award date. If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, additional time may be granted. However, preference will be given to proposals that have U.S. Food and Drug Administration (FDA) approval at the time the award is made. If the trial is multi-institutional, applicants should include plans for communication and real-time data transfer between the collaborating institutions as well as how specimens and/or imaging products obtained during the study will be handled in the appropriate sections of the Clinical Protocol. An intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials as part of the Supporting Documentation. Important aspects of the Clinical Trial Award are as follows: . The proposal must include a named study coordinator who will guide the clinical protocol through Institutional Review Board (IRB), Human Subjects Research Review Board (HSRRB), and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. . IRB approvals should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. . The results of the clinical trial should have a clear and important impact. . The clinical trial must have clearly defined and appropriate endpoints. . The PI must demonstrate availability of and access to an appropriate patient population that will support a meaningful outcome for the study.