DoD Grant for Breast Cancer Clinical Research Extension

The FY22 BCRP Clinical Research Extension Award aims to extend the data collection, follow- up, and analysis of breast cancer clinical research studies. The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to limited or early termination of patient follow-up and sample collection and analysis. The critical components of this award mechanism are:

Impact: Research supported by the FY22 BCRP Clinical Research Extension Award will have the potential for a major impact and accelerate progress toward ending breast cancer. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.

Research Scope: Although not all-inclusive, research proposed under the FY22 BCRP Clinical Research Extension Award may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients currently/previously enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis testing/generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. The award may not be used to directly support a clinical trial.

Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. Applications are strongly encouraged to also describe the clinical relevance of the proposed research. The applicant must demonstrate availability of, and accessibility to, the necessary resources or populations to accomplish the proposed research.

Data Evaluation and Sharing: Proposed research should be based on study sample size that will ensure that the results support valid conclusions and further translation towards clinical application. It is the applicant’s responsibility to provide sufficient evidence that the sample size is appropriate to meet the study’s objectives. The applicant must outline a plan to share the experimental platforms and molecular data generated from the proposed research with the scientific community.

Partnering PI Option: The FY22 BCRP Clinical Research Extension Award encourages applications that include meaningful and productive collaborations between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (PIs). One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring a distinct contribution to the application; collaborations between basic science and clinical researchers are highly encouraged. 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 application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. The application is expected to describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

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, and it is the applicant’s responsibility to outline the advocates’ role in the design and execution of the study. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they may not be employees of any organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.