The FY21 PCRP Data Science Award mechanism supports research where quantitative and analytical approaches, processes, and/or systems are developed and/or used to obtain knowledge and insight from large and/or complex sets of prostate cancer data. If successful, the studies will enable progress towards addressing one or more of the FY21 PCRP Overarching Challenges. It is expected that any tools or data sets generated by this award will be made available for public use. This mechanism is intended to fund research built upon the logic, concepts, and methods of one or more of the following research areas as they pertain to prostate cancer:
• Computational biology
• Bioinformatics
• Artificial intelligence and machine learning
• Epidemiology
• Analysis of –omics data
• Medical Imaging
• Digital Pathology
• Analysis of other clinically annotated datasets
Applications may combine diverse data types for integrative analysis to increase knowledge about prostate cancer with respect to the FY21 PCRP Overarching Challenges. Applications that propose to develop resources or tools that allow research, clinical care, and patient community access to standardized and harmonized datasets for real-time clinical care applications are of particular interest, however this award must not be used to support the development of new datasets. Studies utilizing data derived from large patient studies that include long-term health records or repositories with well-annotated and high-quality biospecimens are encouraged. The data set used in the study must be of sufficient size to provide appropriate analytical and statistical power.
KEY FEATURES
• Research Approach: Applications may propose development of a new data-science-driven tool or apply an existing tool or method to gather and analyze information from large data sets with the intent of advancing prostate cancer research and patient care relative to the FY21 PCRP Overarching Challenges. Applicants are encouraged to consider including plans for rigorous validation, benchmarking, comparisons, and/or evaluations to assess the quality or utility of the tools and/or approaches that will be used or developed under this award. Any data sets used in the study design must be from established, retrospective databases and be sufficient in size to provide appropriate analytical and statistical power. Prospective recruitment of human subjects and/or clinical trials are not allowed under this funding opportunity. Applicants are expected to provide documentation demonstrating access to the appropriate datasets and/or patient samples in numbers sufficient to achieve robust results. Studies leveraging retrospective data and/or ongoing clinical trials are encouraged to provide letters of support indicating access to, and the availability of, the desired resources to support the study.• Impact: Applications are required to clearly communicate how the proposed quantitative and/or analytical approaches, processes, and/or systems will address and provide a solution to one or more of the FY21 PCRP Overarching Challenges. The potential impact of the research, both short- and long-term, should be clearly described, including how the anticipated outcomes or products are distinct from existing research efforts in this area and/or how they will significantly outperform current approaches in this area. High-impact research will, if successful, significantly advance prostate cancer research and/or patient care.
• Data and Resource Sharing Plan: It is expected that any resources, tools, and computational processes that are developed under this award will be openly shared with the research and patient community. Plans must be provided for how additional data generated by future studies will be incorporated to further inform and refine the data science tools, processes, and/or methods generated and/or used in this study. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.
Partnering Principal Investigator (PI) Option: The FY21 PCRP Data Science Award encourages applications that include meaningful and productive collaborations between investigators. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application; collaborations between data scientists and clinicians are highly encouraged. The Partnering PI Option is structured to accommodate two 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. 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. 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.
The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.
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 FY21 PCRP priorities.
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 the 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.
The anticipated direct costs budgeted for the entire period of performance for an FY21 PCRP Data Science Award will not exceed $1.0M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.
The CDMRP expects to allot approximately $4.8M to fund approximately three FY21 PCRP Data Science Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, as well as the number of applications received, the quality and merit of the applications as evaluated by scientific 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.
Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Development Command (USAMRDC) Office of Research Protections (ORP), Human Research Protection Office (HRPO) prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.
If the proposed research is cooperative (i.e., involves more than one institution), a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Clinical research is defined as: (1) patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.
Clinical trials are not allowed. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military patient populations and/or DOD or VA 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. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.