DoD Breast Cancer, Transformative Breast Cancer Consortium Development Award

The FY24 Transformative Breast Cancer Consortium Development Award is intended to provide successful applicants the time and resources needed to bring investigators and breast cancer advocates together to establish a consortium framework and conduct preliminary research to support application to a future, full Transformative Breast Cancer Consortium Award (pending availability of funds). This is a development award and is a separate mechanism from the full consortium award. Recipients of the FY24 Transformative Breast Cancer Consortium Development Award are expected to submit an application to compete for the full Transformative Breast Cancer Consortium Award anticipated to be offered in a future fiscal year(s). However, it is not necessary to receive a development award in order to apply for a full consortium award in the future. For FY24, investigators may be named as Consortium Director on an application submitted to either (but not both) of these mechanisms. Detailed information on the FY24 Transformative Breast Cancer Consortium Award is available under a separate program announcement (HT942524BCRPTBCCA).The FY24 Transformative Breast Cancer Consortium Development Award provides support to: Develop the infrastructure of a multi-institutional research team inclusive of scientists, clinicians, and breast cancer advocates (e.g., building appropriate collaborations, outlining integration, research management, administrative management, and communication plans, and devising an intellectual property plan) Generate necessary preliminary data to serve as proof of concept or for project integration Acquire research resources Develop a framework of necessary statistical analysesBreast cancer consumer advocates must be active participants in the development and execution of the Transformative Breast Cancer Consortium Development Award.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, 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 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.Research involving human subjects and research involving human anatomical substances and data is permitted; however, clinical trials are not allowed under this funding opportunity.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.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.(3) Outcomes research and health services research that do not fit under the definition of clinical trial.Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.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 Transformative Breast Cancer Consortium Development Award should not exceed $100,000. 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 $0.16M to fund approximately one Transformative Breast Cancer Consortium Development 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.