DOD Neurofibromatosis, Clinical Trial Consortium Award

Description

The NFRP Clinical Trial Consortium Award mechanism was first offered in FY06, and subsequently in FY11 and FY16, with awards being made as grants or cooperative agreements. This FY21 research announcement is being offered through a different type of award mechanism, a Research Other Transaction Award (rOTA) under the authority of 10 USC 2371. The FY21 NFRP Clinical Trial Consortium Award is intended to support a major goal/product-driven consortium of exceptional institutions and investigators that will accelerate the clinical translation of basic NF research and ultimately decrease the impact of the disease. The objectives of the rOTA are the conception, design, development, and conduct of collaborative Phase I and II clinical evaluations of promising therapeutic agents for the management or treatment of NF1, NF2, and schwannomatosis.Research Other Transaction Agreement The principal purpose of a rOTA is to carry out non-duplicative basic, applied, and advanced research projects rather than the acquisition of property or services for the direct benefit or use of the government. The anticipated deliverables to the government under a rOTA are reports on research rather than prototypes. Additionally, a rOTA has several features that differ from those of the previous award types offered for the NFRP Clinical Trial Consortium. The rOTA requires resource sharing, with government funds not to exceed the total amount provided by other parties to the maximum extent practicable. Offerors will be required to demonstrate how resources (e.g., cash and non-cash) will be made available for this project. Please also note that the government’s funds will not be front-loaded, with certain matches being required before additional government funds are made available. The rOTA is intended to promote the use of best business practices and to foster relationships among performers from different sectors. In addition, as a matter of DOD policy, rOTAs may only be awarded when one or more for-profit firms are to be involved either in the: (1) performance of the research project(s) or (2) commercial application of the research results. A consortium should either include, collaborate with, or involve one or more for-profit firms in addition to state or local government agencies, institutions of higher education, or other nonprofit organizations. General Information The NFRP Clinical Trial Consortium requires collaboration of multiple organizations and individuals for the purpose of rapidly executing clinical trials. Therefore, the offeror must have a demonstrated history of collaborative research in such a structure. Studies supported by this award will include:  Phase 1 and Phase 2 trials which are the primary focus of this award.  Certain observational trials with appropriate justification and at the discretion of the USAMRAA Agreements Officer. To be included, observational studies will require review by the NFRP Advisory Board and Program Office.  Correlative studies as a part of a trial funded by this award may be considered.  Support for repositories/tissue collection from NFRP Clinical Trial Consortium clinical trials supported may be considered based on the availability of long-term funding, priorities, and resources. The participants will be jointly responsible for prioritizing, proposing, conducting, and analyzing Phase I and Phase II clinical trials focused on therapeutic interventions for NF1, NF2, and schwannomatosis. A final report cumulating the findings for all supported clinical trials will provided at the end of the term of the agreement.

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