DoD Breast Cancer, Clinical Research Extension Award

The FY24 BCRP Clinical Research Extension Award aims to extend or expand the data collection, follow-up, and analysis of breast cancer clinical 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 early trial termination, limited patient follow-up, or suboptimal sample and/or data collection and analysis. Patients' contributions of tissue, serum, and other biologic specimens and their data are invaluable to saving lives. The BCRP has created this mechanism to help ensure that science values those contributions with research that maximizes their impact.The critical components of this award mechanism are:Impact: Research supported by the FY24 BCRP Clinical Research Extension Award will have the potential to extend or affect the impact of the previously funded clinical trial or study or will result in new impact and accelerate progress toward ending breast cancer.Research Scope: Although not all-inclusive, research proposed under the FY24 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 enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis-testing or -generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. Innovation is not a criterion for this award mechanism. Projects proposing to conduct clinical trials will not be supported.Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. 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 a study sample size that will ensure that the results support valid conclusions or will generate a meaningful hypothesis. It is the applicants responsibility to provide sufficient evidence that the sample size is appropriate to meet the study's objectives and outline the statistical methods and considerations they will employ in their data analysis. The applicant must outline a data-sharing plan for the scientific community to have access to the experimental platforms and molecular and other data generated from the proposed research.Partnering PI Option: The FY24 BCRP Clinical Research Extension Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (PIs). One PI will be identified as the Initiating PI, who 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. 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. Applicants are discouraged from being named as a PI, Initiating PI, or Partnering PI on multiple Clinical Research Extension Award applications unless they are clearly addressing distinct research questions. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, 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.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer- Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects that may or may not be considered a clinical trial. For this funding opportunity, research involving human subjects, human specimens, and data, including extended or expanded clinical follow-up of patients, is permitted; however, this award cannot be used to conduct clinical trials.A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Clinical Research Extension Award should not exceed $5M for applications with a single PI or $6M if applying under the Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards supported with FY24 funds will be made no later than September 30, 2025.The CDMRP expects to allot approximately $9.3M to fund approximately one Clinical Research Extension Award application. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.