Design and reporting of phase III oncology trials with prospective biomarker validation.

ABSTRACT:

Background

Phase III trials with prospective biomarker validation are essential to drug development in the era of personalized oncology. However, concerns have emerged regarding the design and reporting of phase III trials with prospective biomarker validation.

Methods

We searched MEDLINE for phase III oncology trials with prospective biomarker validation published in high-impact medical journals from 2011 to 2020. Information regarding trial design and reporting were extracted. Descriptive methods were used to summarize the results.

Results

We identified 45 phase III trials with prospective biomarker validation. There was a trend for increasing use of biomarker validation phase III trials (from 1 trial in 2011 to 12 trials in 2020). For 39 (86.7%) trials, results in

SUBMITTER: Liang F 

PROVIDER: S-EPMC9905966 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature