DOD Neurofibromatosis Clinical Trial Award

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The NFRP Clinical Trial Award (CTA) mechanism was first offered in FY99. Since that time, 21 Clinical Trial Award proposals have been received, and 5 have been recommended for funding. The NFRP CTA supports clinical research with the potential to have a major impact on the treatment or management of neurofibromatosis and/or Schwannomatosis. Funding from this award mechanism cannot be used for preclinical research studies. PIs seeking funding for a preclinical research project should apply to the Investigator-Initiated Research Award mechanism. Areas of Encouragement (Revised for FY09): The FY09 NFRP encourages research proposals that specifically address the critical needs of the NF community in the following areas: • Complications of NF with high mortality such as neoplasms and cerebrovascular abnormalities; DOD Neurofibromatosis Clinical Trial Award 3 • Complications of NF with high morbidity such as skeletal maladies, learning deficits, hormone-associated effects, and pain; • Refinement and standardization of imaging techniques, molecular and cellular markers, and quality of life metrics for use in future clinical trials; and • Translational research such as the development or preclinical testing of therapeutic agents for the treatment of NF. Each application 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 application 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 application) which type of clinical trial is being proposed: Phase 0, Phase I, Phase II, 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 and General Information, 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. See the Program Announcement for the full Funding Opportunity Description.

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