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Congressionally Directed Medical Research Programs -- Toxic Exposures Research Program -- Clinical Trial Award
The FY22 TERP CTA is intended to support the rapid implementation of clinical trials with the potential to have a significant impact on the prevention, treatment, or management of symptoms, diseases, or conditions associated with or resulting from toxic exposures. To meet the intent of the award mechanism, applications must address at least one of the FY22 TERP Programmatic Goals and at least one of the FY22 TERP Topic Areas.
Proposed projects may range from small proof-of-concept clinical trials (e.g., pilot, first-inhuman, phase 0) designed to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. It is anticipated that outcomes from studies funded by this award will follow a clinical development plan that advances the research to FDA device or drug approval and/or establishment of clinical practice guidelines, as applicable.
Applications to the TERP CTA mechanism must support a clinical trial and may not be used for animal or preclinical research studies. The application will be withdrawn if the proposed research is not a clinical trial.
• Required Pre-Application Submission Deadline: November 3, 2022
• Application Submission Deadline: December 1, 2022
Areas of Interest
Climate and health
Extramural and intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent) may be named by the organization as the PI or Partnering PI(s) on the application.
The anticipated direct costs budgeted for the entire period of performance for an FY22 TERP CTA will not exceed $1,500,000 for the Single PI Option and $2,500,000 for the Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.