FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 32338703.
- Also identified by DOI 10.1001/jamainternmed.2020.1097 and PMC identifier 7186918.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.
Medical subject headings
- Antineoplastic Agents
- Biomarkers, Tumor
- Drug Approval
- Neoplasms
- United States Food and Drug Administration