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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  5. Priority Area 2: Stimulate Innovation in Clinical Trials & Personalized Medicine
  1. Advancing Regulatory Science

Priority Area 2: Stimulate Innovation in Clinical Trials & Personalized Medicine

Patient receiving treatment, doctor consutling staff, patient receiving infusion therapy

FDA is collaborating with partners and funding extramural research such as the BAA projects below to help develop the new tools and approaches needed to catalyze the development of personalized medicine--or precision medicine--and to modernize and advance the science and conduct of clinical trials.

 

Extramural Research Funded through the BAA

  1. Sensitivity Analysis Tool for Randomized Trials with Missing Data
  2. Development of a Multicenter Gram-Negative Database to Establish Clinically Relevant Antibiotic Breakpoint Interprative Data
  3. New Design and Analysis Tools for Randomized Trials, with Clinical Applications in Stroke, Cardiac Resynchronization Therapy, Alzheimer’s Disease, and HIV Prevention
  4. Development of a Patient Reported Outcome (PRO) Instrument in Hospital-Acquired Bacterial Pneumonia
  5. Characterization of epilepsy patients at-risk for adverse outcomes related to switching antiepileptic drug products
  6. Analysis of FDA Clinical Trial Data to Improve the Assay Sensitivity and Informativeness of Analgesic Clinical Trials
  7. Consortium for Tuberculosis Biomarkers Biorepository

 

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