DoD Prostate Cancer, Population Science and Outcomes Research Award

Description

The FY20 PCRP Population Science and Outcomes Research Award mechanism supports population-focused studies that will, if successful, identify and understand predictors of lethal prostate cancer or improved survivorship within the context of the FY20 PCRP Overarching Challenges. As such, applications are required to address and provide a solution to one or more of the FY20 PCRP Overarching Challenges. The potential impact of the research, both short- term and long-term, in addressing the FY20 PCRP Overarching Challenge(s) should be clearly described.The overall goal of this award is to generate data and/or tools that can only be achieved from the perspective of systematic studies focused on specific populations of individuals. Research ideas may include, but are not limited to, biomarkers for lethal disease, genetics/genomics, predictors of response or resistance to therapy, survivorship, and health disparity. Such studies will be built upon the logic, concepts, and methods of one or more population sciences including but not limited to:• Epidemiology• Surveillance• Health services research• Outcomes research• Behavioral science• Social science• Dissemination researchApplications may propose retrospective or prospective studies, and may integrate case control, cohort, or other population science study designs (including the use of biospecimens and data from established databases and ongoing clinical trials), provided the proposed sample is of sufficient size to generate findings with ample statistical power. The study should address a well-developed hypothesis that is conceptually sound and specific for prostate cancer. The inclusion of preliminary data to support the study rationale and/or feasibility is strongly encouraged, but not required.The application should include a clearly articulated description of the study population, and a strong statistical analysis plan including statistical expertise and a power analysis reflecting sample size projections that will clearly answer the objectives of the study. Applicants are expected to provide documentation demonstrating access to, and ability to recruit as applicable, the appropriate population(s), patient samples, and/or datasets in numbers sufficient to achieve statistical significance. Studies leveraging retrospective data and/or ongoing clinical trials are encouraged to provide letters of support indicating access to, and availability of, the desired resources to support the study.Investigators whose studies require the use of retrospectively collected human anatomical substances or correlated data are strongly encouraged to consider utilizing the PCRP-funded Prostate Cancer Biorepository Network (PCBN) (http://www.prostatebiorepository.org) and/or the North Carolina – Louisiana Prostate Cancer Project (PCaP) (https://pcap.bioinf.unc.edu).Investigators considering use of these or other resources are highly encouraged to provide a letter of support indicating access to, and availability of, the desired resources to support the study.Research involving human subjects is permitted under this funding opportunity but is restricted to studies without clinical trials. Principal Investigators (PIs) may participate in clinical trials as part of their research project, but funding for such clinical trials must come from sources other than this award. Correlative studies associated with an existing clinical trial are particularly encouraged, provided they are determined to be no greater than minimal risk by the Institutional Review Board (IRB) of record and the U.S. Army Medical Research and Development Command (USAMRDC) Office of Research Protections (ORP), Human Research Protection Office (HRPO).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.Investigators seeking funding for a clinical trial are encouraged to consider submitting an application to the FY20 PCRP Clinical Trial Award (Funding Opportunity Number: W81XWH- 20-PCRP-CTA).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 thelives of advanced state and recurrent patients. As a member of the Metastatic Cancer TaskForce, 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 FY20 PCRP priorities.The anticipated direct costs budgeted for the entire period of performance for an FY20 PCRP Population Science and Outcomes Research Award will not exceed $1M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2021. For additional information refer to Section II.F.1, Federal Award Notices.

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