DoD Prostate Cancer, Idea Development Award 2024

The FY24 PCRP Idea Development Award is intended to support new ideas that represent innovative approaches to prostate cancer research and have the potential to make an important contribution to the PCRP mission. The key components of this award mechanism are: Innovation: Research deemed innovative may represent a new paradigm, challenge current paradigms, look at existing problems from new perspectives, leverage unique study populations, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative. Projects involving multidisciplinary and/or data science approaches are especially encouraged. Impact: Applications are required to address and provide a solution to one or more of the FY24 PCRP Overarching Challenges. The potential impact of the research, both short-term and long-term, in addressing the FY24 PCRP Overarching Challenge(s) should be clearly described. High-impact research will, if successful, significantly advance prostate cancer research and/or patient care. Preliminary Data: Due to this awards emphasis on innovation, the presentation of preliminary data relevant to prostate cancer and the proposed project is encouraged, but not required. Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team. Regardless of whether preliminary data are included, applications should be based on a sound scientific rationale that is established through logical reasoning and/or critical review and analysis of the literature.New Investigator category: The FY24 PCRP Idea Development Award mechanism encourages research ideas from investigators in the early stages of their careers. The New Investigator category of this award mechanism is designed to allow applicant organizations to name PIs who are early in their faculty appointments or in the process of developing independent research careers. Applications submitted to the New Investigator category will be assessed using different review criteria for personnel (refer to Section II.E.1.a., Peer Review) and are required to include a collaborator (or collaborators) who has (have) experience in prostate cancer research, as demonstrated by a record of funding and publications. The application must describe the potential of the collaboration(s) to be successful and how the collaboration(s) will augment the PIs expertise to better address the research question. In addition, applicants are strongly encouraged to provide a letter of collaboration from the collaborator(s) describing the collaborator(s) involvement in the proposed work. All applicants for the New Investigator category must meet specific eligibility criteria described in Section II.C, Eligibility Information.Multidisciplinary projects are encouraged, and multi-institutional projects are allowed. Each proposed study must include a clearly stated plan for interactions among all team members and organizations involved. The plan must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.Investigators are strongly encouraged to incorporate the following components into their study design, where appropriate, in order to maximize the potential impact of the proposed research project: authentication of proposed cell lines; statistical rigor of preclinical animal experiments; and incorporation of experiments to assess clinical relevance and translatability of findings. Studies utilizing data that are derived from large patient studies that include long-term health records, biospecimen repositories, and pre-existing research and apply state-of-the-art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. Investigators are highly encouraged to provide a letter of support indicating access to and the availability of any resources required to support the study.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 PCRP 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.Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 https://www.nature.com/nature/ journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.Clinical trials are not allowed. 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 PCRP Idea Development Award should not exceed $1.2M. 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 $53.76M to fund approximately 28 Idea Development Award applications. 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.