Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
PAR:PAR-25-450.htmlPurpose: 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 calcul…
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…
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