Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 30027239.
- Also identified by DOI 10.1001/jama.2018.7619 and PMC identifier 6583484.
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Abstract
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.
Medical subject headings
- Clinical Trials as Topic
- Drug Approval