Incidence of Primary End Point Changes Among Active Cancer Phase 3 Randomized Clinical Trials.

ABSTRACT:

Importance

Primary end point (PEP) changes to an active clinical trial raise questions regarding trial quality and the risk of outcome reporting bias. It is unknown how the frequency and transparency of the reported changes depend on reporting method and whether the PEP changes are associated with trial positivity (ie, the trial met the prespecified statistical threshold for PEP positivity).

Objectives

To assess the frequency of reported PEP changes in oncology randomized clinical trials (RCTs) and whether these changes are associated with trial positivity.

Design, setting, and participants

This cross-sectional study used publicly available data for complete oncology phase 3 RCTs registered in ClinicalTrials.gov from inception through February 2020.

Main outcomes a

SUBMITTER: Florez MA 

PROVIDER: S-EPMC10193180 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature