DoD Prostate Cancer, Synergistic Population and Data Science Award

Description

The Synergistic Population and Data Science Award mechanism supports multi-institutional partnerships that will leverage existing prostate cancer patient datasets or cohorts to answer questions that will make a significant impact in addressing the FY19 PCRP Overarching Challenges. Thus, applications must be responsive to at least one of the FY19 PCRP Overarching Challenges. The award is intended to support both the development of infrastructure to facilitate access to multiple datasets/cohorts by a team of investigators, as well as conducting hypothesis-based studies utilizing the multi-institutional datasets. To qualify for this mechanism, a minimum of three institutions and three well-annotated patient datasets/cohorts is required. Dataset Coordination: Central to the pursuit of the hypothesis proposed in the application is the development of the infrastructure to facilitate multi-institutional access to the identified datasets/cohorts. The application must describe the key elements that will need to be in place in order to facilitate the multi-institution collaboration, including: • Administrative and management plans for decision-making and allocation of resources • Description of the dataset logistics, including storage, how data will be shared among PIs/institutions, and plans for data harmonization • Description of key members and roles of the multi-institutional research team • Communication plans among the research team members to discuss research progress and results • Regulatory plan, including coordination of local Institutional Review Board (IRB) approvals • Data security and integrity measures • Intellectual property plan • Plan for disseminating information and distributing data to the prostate cancer research community Synergistic Research Team: The Synergistic Population and Data Science Award mechanism requires the collaboration of a minimum of three Principal Investigators (PIs) at three or more institutions or organizations. 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 PIs will be identified as Partnering PIs. Initiating and Partnering PIs each have different submission requirements, as described in Section II.D.2, Content and Form of the Application Submission; however, all PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work, and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. The Initiating PI is expected to have experience in successfully leading the design, administration, and management of multi-institutional research projects. The PI should create a virtual environment that fosters and supports collaboration and creativity, with consistent, intensive interaction within the research team in a way that engages all investigators in all aspects of the research project. The epidemiologic and/or biostatistical expertise of the study team should be clearly described and evident in the study plan. Research Project: Subsequent to the establishment of the infrastructure needed to facilitate the research collaboration, it is expected that the research team will utilize the multi-institutional patient datasets/cohorts to address a central hypothesis that could only be addressed through systematic studies of the assembled datasets/cohorts. The outcomes of the proposed research project should have the potential to make a substantial impact on addressing the FY19 PCRP Overarching Challenges. Applications may propose case control, cohort, or other population or data science study designs (including the use of biospecimens and data from established retrospective databases), provided the study is retrospective and the population is of sufficient size to provide appropriate 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 statistical significance. New FY19 definition: A clinical trial is 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. 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 FY19 PCRP priorities. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. The anticipated direct costs budgeted for the entire period of performance for an FY19 PCRP SPDSA will not exceed $1,500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $2.4M to fund approximately one Synergistic Population and Data Science Award application. 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 FY19 funding opportunity will be funded with FY19 funds, which will expire for use on September 30, 2025. Awards will be made no later than September 30, 2020. For additional information refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. An assistance agreement (grant or cooperative 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. 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 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. 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 Materiel Command (USAMRMC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Applications that involve recruitment of human subjects must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work (SOW). Successful applicants will work with USAMRAA to establish milestones for human subjects recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap

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