The FY24 PRCRP ACCCTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of cancer within at least one of the FY24 PRCRP Topic Areas.

Clinical trials may be designed to evaluate promising new products, pharmacologic

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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) that evaluate the effects of interventions or inform the design of more advanced trials to large-scale trials to determine efficacy in relevant patient populations.

Funding from this award mechanism must support a clinical trial.

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 or 18 months after the award date for studies regulated by the Regulatory Agency.

· 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 FY24 PRCRP Topic Areas and address one of the FY24 PRCRP Military Health Focus Areas and one of the FY24 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 IND/ 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.

· 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 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 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.