Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

The KCRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of kidney cancer. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

Key aspects of the KCRP Clinical Trial Award Mechanism:

• Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency.

• Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical trial is required.

• Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

• Intervention Availability: The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.

• Personnel and Environment: The application should demonstrate the study team’s expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local IRB of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in Code of Federal Regulations, Title 21, Part 312, Subpart D (21 CFR 312.D), are fulfilled.

• Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.

Organizational-Level Emphasis:

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 and addresses the FY24 KCRP strategic priorities and/focus areas described in Section II.A.1 and Section II.A.2.

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.

Women’s Health: 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 women’s health outcomes and/or advancing knowledge for women’s 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, 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. Funding from this award mechanism must support a clinical trial. A clinical trial is defined in 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.

Applicants seeking funding for research that does not meet this definition should consider one of the other FY24 KCRP program announcements being offered.

For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.

For the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted.

If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an Investigational New Drug (IND) application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be submitted to the relevant regulatory agency by the Clinical Trial Award application submission deadline. The IND, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.

If the investigational product is a device, then submission of an Investigational Device Exemption (IDE), or equivalent, application that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE, or equivalent, is not required. If an IDE, or equivalent, is required, the IDE application, or equivalent, must be submitted to the relevant Regulatory Agency by the Clinical Trial Award application submission deadline. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial.

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 KCRP CTA should not exceed $2,000,000. 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 $6.4M to fund approximately two Clinical Trial 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.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org