The FY23 PRMRP Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on a disease or condition addressed in one of the congressionally directed FY23 PRMRP Topic Areas and FY23 PRMRP Strategic Goals. 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.
Deadlines:
• Required Pre-Application Deadline: April 12, 2023
• Application Submission Deadline: July 19, 2023
Investigators at or above the level of Assistant Professor (or equivalent) may be named by the organization as the PI on the application. Each investigator may be named on only one FY23 PRMRP CTA application as a PI.
The anticipated direct costs budgeted for the entire period of performance for an FY23 PRMRP Clinical Trial Award – Planning Phase with Clinical Trial will not exceed $500,000 for the planning phase, while the budget for the proposed clinical trial is not restricted to a predetermined cost limit. The requested budget for the clinical trial must be justified and appropriate to the scope proposed.
Applications to the FY23 PRMRP Clinical Trial Award – Clinical Trial Only are not restricted to a predetermined cost limit. The requested budget must be justified and appropriate to the scope of the clinical trial proposed. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
