Defense Health Agency Contracting Activity - DHACA
· Federal agency
DoD Kidney Cancer, Clinical Trial Award
The KCRP Clinical Trial Award supports the rapid implementation of 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 t...
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Deadline988 days agoLocationAlabamaTypegrantLevelFederalClosedposted Jun 5, 2023
✦ AI Summary
Who can apply: Federal-level applicants (see eligibility for details).
Funding amount: total funding pool ~$2,400,000.
Next deadline: October 6, 2023.
Issued by: Defense Health Agency Contracting Activity - DHACA.
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Deadline
988 days ago
Oct 6, 2023
Total pool
$2.4M
About this opportunity
The KCRP Clinical Trial Award supports the rapid implementation of 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, 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 a placebo or another 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.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY23 KCRP program announcements being offered. 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, Regulatory Agency refers to the Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.Key aspects of the KCRP Clinical Trial Award:• 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.• 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 FDA processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (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 the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart 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.
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