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.
