DoD Kidney Cancer, Translational Research Partnership Award

The FY24 KCRP Translational Research Partnership Award supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in kidney cancer toward clinical applications. This award supports the development of translational research collaborations between two independent, faculty-level (or equivalent) investigators to address a central problem or question in kidney cancer in a manner that would be less readily achievable through separate efforts. One partner in the collaboration must be a research scientist and the other must be a clinician. It should be clear that both have had equal intellectual input in the design of the research project. Multi-institutional partnerships are encouraged. At least one member of the partnership must have experience either in kidney cancer research or kidney cancer patient care. Inclusion of experts from outside the kidney cancer field is encouraged. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism.Preliminary data to support the feasibility of the research hypothesis and research approaches are required; however, these data do not necessarily need to be derived from studies of kidney cancer.Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinicians firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application that is relevant to active-duty Service Members, Veterans, and/or the American public. However, members of the partnership should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science (bench to bedside and/or bedside to bench). There should be an intellectual synergistic partnership between the clinic and the laboratory.The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award.The following are significant features of this award mechanism:The Translational Research Partnership Award (TRPA) requires two or more 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(s) will be identified as Partnering PI(s). All 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 PI and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission. Partnership: The success of the project should depend on the unique skills and contributions of each partner. Translation: The application should provide evidence for the reciprocal transfer of information between basic and clinical science, or vice-versa, in developing and implementing the research plan. Translational research may include correlative studies and/or development of or use of annotated biorepositories. The application should demonstrate how the study will leverage clinical information to address knowledge gaps in resulting outcomes, validate key research findings, expand upon potentially transformative results, and/or investigate novel findings. Impact: The proposed research should indicate the potential to have a significant impact on kidney cancer research and/or patient care and have the potential to accelerate the movement of promising ideas (in prevention, diagnosis, detection, prognosis, treatment, and/or survivorship) into clinical applications. Clinical trials are not allowed. Feasibility: The application should demonstrate that the investigators have access to the necessary specimens, data, and/or intervention, as applicable. Preliminary Data: Unpublished results from the laboratory of the Principal Investigators (PIs) named on the application and/or data from the published literature that are relevant to kidney cancer and the proposed research project are required.Projects including Correlative Studies: The FY24 KCRP Translational Research Partnership Award may support correlative studies that are associated with an ongoing or completed clinical trial. The application should demonstrate access to the necessary specimens and/or data of the proposed cohort. Appropriate access must be confirmed at the time of application submission. See Attachment 11, Letter(s) Confirming Access to Specimens and/or Data.Organizational-Level Emphasis Areas: The following areas of emphasis are broadly applicable to many CDMRP programs, not just the KCRP. Investigators are encouraged to consider addressing these areas in their applications if doing so is appropriate for their line of research, addresses the FY24 KCRP Overarching Strategic Goals and Focus Areas described in Section II.A., and meets the intent of the Translational Research Partnership Award.Nuclear Medicine: 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.Womens Health: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in womens health outcomes and/or advancing knowledge for womens health.Metastatic Cancer Task Force: 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 KCRP priorities.Rigorous Study Design: 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.Military Service Involvement: 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.Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.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.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 46.104(d)(4) of the Common Rule.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated combined direct costs budgeted for the entire period of performance for an FY24 KCRP Translational Research Partnership Award should not exceed $800,000. 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, 2025.The CDMRP expects to allot approximately $7.68M to fund approximately six Translational Research Partnership 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, 2030.