Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 34751763.
- Also identified by DOI 10.1001/jamanetworkopen.2021.33667 and PMC identifier 8579227.
- 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 examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.
Medical subject headings
- Data Science
- Drug Approval
- Pragmatic Clinical Trials as Topic
- Product Surveillance, Postmarketing