DoD Kidney Cancer, Consortium Development Award

Description

The KCRP seeks to promote a major multi-institutional clinical effort conducted by leading kidney cancer researchers. This effort will be executed through two separate award mechanisms, the Consortium Development Award in FY17 and the anticipated Consortium Award in FY19. Applications for the FY17 Consortium Development Award are being requested in this Program Announcement. The Consortium Development Award is a clinical trial infrastructure mechanism that provides support to create a Coordinating Center and to establish the necessary collaborations at potential Clinical Trial Sites for the development of a multi-institutional kidney clinical effort relevant to active duty Service members, Veterans, other military beneficiaries, and the American public. The goal of the Consortium Development Award is the establishment of the consortium infrastructure for future multi-institutional clinical trials. The eligible applicants of the FY17 Consortium Development Award are expected to submit an application to compete for the Consortium Award anticipated to be offered in FY19. The KCRP expects to fund one FY17 Consortium Development Award, depending on the number and the quality of applications received. The KCRP reserves the right to open the FY19 Consortium Award to all eligible applicants that meet the requirements of the anticipated FY19 Consortium Award, and/or to re-release the Consortium Development Award in FY19 if the goals of the FY17 Consortium Development Award are not met. Consortium Description: The consortium must be a geographically dispersed coalition, including a Coordinating Center and at least three Clinical Trial Sites. All Clinical Trial Sites will be responsible for working collaboratively and providing available research resources to the consortium. The Consortium Director, i.e., the Principal Investigator (PI) of the Coordinating Center, must have a proven track record of leadership and the scientific ability to direct and oversee the overall research effort. The Consortium Development Award will support a strong collaboration of clinicians and researchers to build the overarching structure of a clinical consortium. The PI and the co-PIs in the consortium should be clinicians and scientists who have made significant contributions to the field of kidney cancer research. Clinical infrastructure development includes (but is not limited to) establishing appropriate collaborations, outlining an administrative management plan, developing research management and communication plans, and devising and implementing an intellectual property plan. By the end of the award, the infrastructure should be in place and the mechanics of a clinical consortium initiated to maximize the use of resources and standardization of procedures, and to minimize unnecessary duplication among consortium members; for example, experimental techniques, databases, models, antibodies, biomarker tools, phenotyping processes, etc., should be shared resources for all consortium members. The goal is for the consortium to function as a unit rather than as a collection of different sites, with unified processes pertaining to ethics review, contract management and data sharing. The Coordinating Center and the Clinical Trial Sites should have all regulatory, material, and intellectual property agreements in place by the end of the award. Any delays should be well documented and justified with a mitigation plan in place to be considered for funding under the FY19 Consortium Award. Plans to expand to additional Clinical Trial Sites should be in place by the end of the Consortium Development Award.

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