The FY24 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

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toward addressing one or more of the FY24 PCRP Overarching Challenges.

It is expected that any resources, tools, or computational processes generated by this award will be openly shared with the prostate cancer research and patient community.

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 datasetsApplications may combine diverse data types for integrative analysis to increase knowledge about prostate cancer with respect to the FY24 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.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 datasets with the intent of advancing prostate cancer research and patient care relative to the FY24 PCRP Overarching Challenges.

Inclusion of preliminary data to support the scientific rationale and feasibility of research approaches is strongly encouraged, but not required.

Any preliminary data provided should be from the laboratory of the Principal Investigator(s) (PI[s]) or member(s) of the collaborating team.

Applicants are encouraged to include 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 datasets 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 is 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.• 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 FY24 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 prostate cancer 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.

Refer to the CDMRP’s Policy on Data & Resource Sharing located on the Electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page https://ebrap.org/eBRAP/public/Program.htm for more information about the CDMRP’s expectations for making data and research resources publicly available.Partnering PI Option:
The FY24 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 and execution 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 on separate awards to the recipient organization.

Each award will be subject to separate reporting, regulatory, and administrative requirements.

For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.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 (http://www.nature.com/ nature/journal/v490/n7419/full/nature1155 6. 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 4 6. 102 (45 CFR 4 6. 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 §4 6. 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 Data Science Award should not exceed $ 1. 0M.

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, 202 5. The CDMRP expects to allot approximately $1 1. 2M to fund approximately seven Data Science 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, 203 0.