Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

Department of Health and Human Services

Description
  • Purpose: Fund clinical research that makes rare disease studies “clinical trial–ready” by:

  • Developing, testing, and validating fit-for-purpose biomarkers and clinical outcome assessments (COAs)

  • Defining disease presentation and natural history to inform eligibility criteria, stratification, endpoints, timing of intervention, and power/sample-size calculations

  • Sponsor: NIH’s National Center for Advancing Translational Sciences (NCATS), …

Attaining effective therapies for rare diseases is challenging due to their low prevalence resulting in fewer patients, clinicians, researchers, and resources compared to common diseases. This leads to gaps in our understanding of a rare disease's natural history, and a dearth of suitable biomar…

Source

Grant ID

PAR:PAR-25-450.html

Agency

Department of Health and Human Services

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