Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 34751764.
- Also identified by DOI 10.1001/jamanetworkopen.2021.33601 and PMC identifier 8579231.
- 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 cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
Medical subject headings
- Clinical Trials as Topic
- Drug Approval
- Product Surveillance, Postmarketing