DoD Prostate Cancer, Implementation Science Award

Description

The FY24 PCRP Implementation Science Award supports studies that are expected to bridge the gap between research, practice, and policy through establishment of a knowledge base of interventions, clinical practices/guidelines, tools, and policies that can be deployed to targeted populations at the appropriate time and point of need. For the purposes of this funding opportunity, an implementation science study accesses strategies used and develops tools to enhance the systematic uptake of evidence-based health interventions into clinical and/or community settings in order to improve patient outreach, patient outcomes, and/or the effectiveness of health care.Impact: Research supported by the Implementation Science Award is expected to have the potential for major, near-term impact that will accelerate the widespread adoption of evidence-based practices in prostate cancer care, prevention, and survivorship. Applications are expected to identify the prostate cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Applications must also include a detailed research transition plan that articulates the pathway to moving the project’s findings to the next phase for widespread clinical impact after successful completion of the award. Research transition plans are encouraged to consider future strategies targeting the patient, physician/provider, community, and/or healthcare system levels as applicable.Community Engagement: Applications are required to include members of the targeted population and/or community in the development and execution of the research project where appropriate. The research team must include one or more prostate cancer consumer advocate(s) or member(s) of the community, who will be integral throughout the planning and performance of the research project. Consumer advocates and/or community-based members should be involved in the development of the research question, project design, oversight, recruitment, and evaluation and dissemination of outcomes, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings; communication between the research team and the community should be frequent and bidirectional. The consumer advocates can be individuals who have been diagnosed with prostate cancer, a direct caregiver for someone who has been diagnosed with prostate cancer, or other representatives from the targeted community who are positioned to effect change. The consumer advocates and/or community-based members should have a high level of knowledge of current prostate cancer issues and the appropriate background in prostate cancer research and/or clinical care to contribute to the project or be otherwise positioned within the target community to effect changes in behavior based on projected outcomes. A list of implementation science resources and community or advocacy organizations is provided at the end of the Implementation Science Award Information section.Health Equity and Disproportionately Affected Populations: Regardless of the FY24 PCRP Overarching Challenge(s) being addressed, all research projects are strongly encouraged to consider health equity (e.g., access to evidence-based care) and/or have a focus on addressing the needs of disproportionately affected populations in the application.Research Scope: The Implementation Science Award mechanism is intended to fund studies including, but not limited to, the following:• Small-scale clinical trials (up to phase 2) that contain clear reporting and implementation strategies to narrow the research-to-practice timeline and improve care for prostate cancer survivors, particularly within disproportionately affected populations• Interventions that focus on behavioral or lifestyle changes at the patient, provider, community, and/or policy level• Comparative effectiveness research establishing the benefits and harms of emerging or standard-of-care interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings• Development and evaluation of strategies to overcome barriers to health care access across the cancer care continuum• Altering the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines.Preliminary data to support the scientific rationale and feasibility of the research approaches are required. These preliminary data do not need to have been generated solely in prostate cancer. The inclusion of additional preliminary data to support the clinical relevance of the idea is strongly encouraged.Investigators proposing a clinical trial are highly encouraged to consider leveraging the PCRP Prostate Cancer Clinical Trials Consortium (https://pcctc.org) to facilitate the rapid initiation and completion of the trial.Correlative studies that are associated with ongoing clinical trials, and preclinical studies involving the use of animals do not meet the intent of the FY24 PCRP Implementation Science Award.Partnering Principal Investigator (PI) Option: The FY24 PCRP Implementation Science Award encourages applications that include meaningful and productive collaborations between two investigators. The PIs may have expertise in similar or disparate scientific and/or clinical disciplines, but each PI is expected to bring distinct contributions to the application. 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. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, 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 prioritiesInnovative 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.A Clinical Trial Option allows for studies proposing small-scale clinical trials with a focus on implementation science. 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. Applications proposing a clinical trial are expected to provide detailed plans for initiating the clinical study within the first year, including U.S. Food and Drug Administration (FDA) Investigational New Drug/Investigational Device Exemption application submission plans, within 60 days of the award.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 huma

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