DOD Kidney Cancer, Clinical Trial Award

Description

The KCRP Clinical Trial Award supports the rapid implementation of early-phase clinical trials (phase 0, phase 1, phase 1/2) 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, surgical procedures, behavior modifications, clinical guidance, and/or emerging approaches and technologies. Therapeutic approaches testing existing interventions for new indications in kidney cancer are also encouraged. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform kidney cancer patient care.Funding from this award mechanism must support a clinical trial. 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. For more information, a Human Subject Resource Document is provided at https://cdmrp.army.mil/pubs/pdf/Human% 20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY21 KCRP program announcements being offered.Investigational New Drug Requirements: If the proposed clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required. It is the responsibility of the applicant to provide evidence from the Institutional Review Board (IRB) of record or the FDA if an IND is not required. If an IND is required, the IND application must be submitted to the FDA by the FY21 KCRP Clinical Trial Award application submission deadline. The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm.Investigational Device Exemption Requirements: If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IDE is not required or if the device qualifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted to the FDA by the FY21 KCRP Clinical Trial Award application submission deadline. The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial.If the clinical trial of an investigational product will be conducted at international sites, evidence that an application to the relevant national regulatory agency of the host country(ies) has been submitted by the FY21 KCRP Clinical Trial Award application submission deadline is required.Key Requirements: The following are important aspects of the FY21 KCRP Clinical Trial Award:• The proposed clinical trial is expected to begin no later than 12 months after the award date.• The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by kidney cancer.• Inclusion of preliminary data relevant to the proposed clinical trial is required.• The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the relevant literature.• The application should describe the planned indication for the product label, if appropriate, and include an outline of the product development plan required to support that indication.• The application should demonstrate 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 and how standards of care may impact the study population.• The application must demonstrate documented availability of and access to the drug/ compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study. The quality and stability of the product should be documented and commensurate with current FDA manufacturing standards applicable to the type and phase of product being developed (i.e., Quality System Regulation, Good Manufacturing Practice [GMP] guidelines). Funds from this award may not be used to support costs associated with producing or acquiring the specified intervention (i.e. purchasing from the manufacturer).• The application should reflect the study team’s experience interacting with the FDA, including previous FDA submissions, if applicable.• The proposed clinical trial design should include clearly defined objectives and appropriate endpoints/outcome measures, and comply with current Good Clinical Practice (GCP) guidelines.• The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will answer the objectives of the study.• The application should include a clearly articulated data management plan and use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.• The application should include a clearly articulated safety management plan outlining how safety pharmacovigilance will be conducted, as applicable.• The application should include a clearly articulated clinical monitoring plan outlining how the study will be monitored for GCP compliance.• 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 include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical trial phase and/or delivery to the market after the successful completion of the FY21 KCRP Clinical Trial Award.• The application should clearly demonstrate strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled.• Funded trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219.Funded studies are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section D, for further details.The types of awards made under the program announcement will be assistance agreements. An assistance 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. 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. 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, but is not limited to, 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.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 FY21 KCRP priorities.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the Ameri

Eligibility

Grants.gov lists this opportunity under eligibility category code 99. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.

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