DoD Breast Cancer, Breakthrough Award Levels 3 and 4

Description

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are: Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Research Scope: Research proposed under this award mechanism may be small- to large-scale projects, at different stages of idea and research development. Two different funding levels, based on the scope of the research, are available under this Program Announcement. This Program Announcement discusses Funding Levels 3 and 4. Funding Levels 1 and 2 will be available under a different Program Announcement (W81XWH-18-BCRP-BTA12-2). When submitting the pre-application, it is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget. The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level: Funding Level 3: Advanced translational studies that have potential for near-term clinical investigation. Small-scale clinical trials may apply. Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Near-term clinical impact is expected. Human clinical testing is required. PIs are expected to have experience in successfully leading large-scale projects. Note: An invited oral presentation is a requirement for application review of Funding Level 4 projects, as described in Section II.D, Full Application Submission Content. Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive collaborations between investigators. The Partnering PI Option is structured to accommodate two PIs, referred to as the Initiating PI and the Partnering PI, each of whom will be funded with a separate award. There are different submission requirements for the Initiating and Partnering PIs’ applications; however, both PIs should contribute significantly to the development of the proposed research project including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. New collaborations are encouraged, but not required. The application is expected to describe how the PIs’ combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Levels 3 and 4 applications unless they are clearly addressing distinct research questions. Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project. Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. The consumer advocates should have a high level of knowledge of current breast cancer issues and the necessary background or training in breast cancer research to contribute to the project. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.

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