DoD Peer Reviewed Cancer, Advancing Cancer Care through Clinical Trials Award

The summary for the DoD Peer Reviewed Cancer, Advancing Cancer Care through Clinical Trials Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.
DoD Peer Reviewed Cancer, Advancing Cancer Care through Clinical Trials Award: The PRCRP ACCCT Award supports clinical trials that will progress to the next stage of study or improve the standard of care for individuals living with cancer within at least one of the FY23 PRCRP Topic Areas. The ACCCT Award mechanism requires a clinical trial for transition of and the advancement of previously completed pre-clinical research to the clinic. 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. 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 PRCRP 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 U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted. Key aspects of the PRCRP Award Mechanism: · Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 12 months after the award date and have recruited at least two study participants. · Impact: The proposed intervention(s) to be tested should offer significant potential for advancing to the next stage of clinical study, transition of results to fielded science, or improve the standard of care for at least one of the FY23 PRCRP Topic Areas and address one of the FY23 PRCRP Military Health Focus Areas and one of the FY23 PRCRP Overarching Challenges. The impact of the intervention should include considerations of quality of life and supportive care during the trial. · Supportive preclinical data are required: Inclusion of supportive preclinical data relevant for the clinical trial is required. No proposed preclinical research to support an Investigational New Drug (IND)/Investigational Device Exemption (IDE) application is allowed. The data presented to support the initiation of a clinical trial is required. No animal work is allowed. · 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 IRB review) are exempt from this requirement. Inclusion of women and minority populations will be assessed. · 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 at least one 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. If required by a regulatory agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards. · Milestones: The application should include a clearly articulated milestone plan, including a plan for IRB approval and accrual of at least two study participants by the end of the first year from the award start date.
Federal Grant Title: DoD Peer Reviewed Cancer, Advancing Cancer Care through Clinical Trials Award
Federal Agency Name: Dept of the Army USAMRAA (DOD-AMRAA)
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: HT9425-23-PRCRP-ACCCT
Type of Funding: Cooperative Agreement
CFDA Numbers: 12.420
CFDA Descriptions: Information not provided
Current Application Deadline: September 27th, 2023
Original Application Deadline: September 27th, 2023
Posted Date: April 4th, 2023
Creation Date: April 4th, 2023
Archive Date: October 27th, 2023
Total Program Funding: $28,800,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards: 6
Cost Sharing or Matching: No
Last Updated: April 4th, 2023
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity below), subject to any clarification in text field entitled "Additional Information on Eligibility"
Grant Announcement Contact
CDMRP Help Desk
Phone: 301-682-5507
Email: [email protected]
CDMRP Help Desk
Similar Government Grants
DoD Ovarian Cancer Ovarian Cancer Academy - Early-Career Investigator Award
DoD Peer Reviewed Medical, Impact Award
DoD Peer Reviewed Medical, Lifestyle and Behavioral Health Interventions Research Award
DoD Peer Reviewed Medical, Discovery Award
DoD Peer Reviewed Medical, Technology/Therapeutic Development Award
FY2006 Deployed War Fighter Protection Research Program
Department of Defense (DOD) Fiscal Year 2003 (FY03) Breast Cancer Research Program (BCRP)C...
Department of Defense (DOD) Fiscal Year 2004 (FY04) Breast Cancer Research Program (BCRP) ...
More Grants from the Dept of the Army USAMRAA
DoD Peer Reviewed Medical, Impact Award
DoD Peer Reviewed Medical, Lifestyle and Behavioral Health Interventions Research Award
DoD Peer Reviewed Medical, Clinical Trial Award

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2007-2024 FederalGrants.com