Timing of first-in-child trials of FDA-approved oncology drugs.

ABSTRACT: AIM:The lag time between initial human studies of oncology agents and the first-in-child clinical trials of these agents has not been defined. METHODS:We conducted a systematic analysis of time from first-in-human trials to first-in-child trials (age of eligibility <18 years) of agents first approved by the US Food and Drug Administration (FDA) for any oncology indication from 1997 to 2017. We used clinical trial registry data, published literature and oncology abstracts to identify relevant trials and start dates. RESULTS:From 1997 to 2017, 126 drugs received initial FDA approval for an oncology indication. Of these, 117 were non-hormonal agents used in subsequent analyses. Fifteen of 117 drugs (12.8%) did not yet have a paediatric trial, and six of 117 drugs (5.1%) had an initial approva

SUBMITTER: Neel DV 

PROVIDER: S-EPMC6491224 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature