Department of Defense Neurofibromatosis Clinical Consortium Award

The NF Clinical Consortium needs to be a collaboration of multiple organizations and individuals for the purpose of rapidly executing clinical trials. The Consortium must consist of a single Operations Center and a minimum of five Clinical Trial Sites with a demonstrated history of collaborative research. 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.

The Operations Center and associated Clinical Trial Sites must apply to this announcement through a single application submitted by the Operations Center. The Operations Center may also serve as a trial site. A single award will be made to the Operations Center. Award funds are to be used to support the Operations Center’s efforts as well as Consortium-associated studies at through the appropriate subcontract or other instruments for the Clinical Trial Sites.

Award selection will be based on evaluation of the proposed plans for initial clinical trials to be implemented, available capabilities, organization of the Consortium, and feasibility of the collective group to accomplish the overall award objectives (see Section III.B., Application Review Process). During the performance period of the award, the Operations Center and all Clinical Trial Sites will be responsible for working collaboratively to identify new clinical trials for implementation by the Consortium.

The NFRP is allocating a total of $9M in support of the Consortium. The Consortium will be funded initially for a total of $5M with allocations from the FY16 NFRP Congressional appropriation. Two additional option periods, to be included in the application, will be funded for a total of $2M each (minimum of 1 trial per option must be proposed), subject to receipt of future Congressional appropriations. See Section I.D., Funding, for additional information.