Trends in FDA cancer registration trial design over time, 1969-2020.
Plain-language summary
This study reviewed the package inserts of 258 FDA-approved oncology drugs to examine how the design of trials supporting cancer drug approvals changed from 1969 to 2020, linking trials to the HemOnc ontology and grouping them into four designs (escalation, in-class comparison, out-of-class switch, and de-escalation). Of 556 registration trials identified, 372 (67%) were randomized controlled trials, and approvals rose exponentially over time. This is a conference abstract.
Read the full paper (DOI: 10.1200/JCO.2020.38.15_suppl.2060).
This is a plain-language summary written for discoverability; the authoritative version is the published paper. Part of Travis Osterman's peer-reviewed publications.