Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First Approval

摘要

Background: In 2012, the US Food and Drug Administration (FDA) issued the draft guidance Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations. The selective data collection approach proposed in this guidance leads to reductions in costs and work time and may improve the quality of the database for clinical trials. The current study evaluated the applicability of selective data collection for oncology drugs.