Trials that turn from retrospectively registered to prospectively registered: a cohort study of "retroactively prospective" clinical trial registration using history data.

ABSTRACT:

Background

Prospective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elements, including the start date, may change before the first patient is enrolled. If a trial changes its start date after recruiting began, however, it may indicate a reason for concern. This study aimed to measure the rate of "retroactively prospective" trials. This refers to trials that are originally registered retrospectively, with the start date before the registration date, but that retroactively change their start date to be after the registration date, making them appear as if they were prospectively registered.

Methods

We retrieved clinical trial histor

SUBMITTER: Holst M 

PROVIDER: S-EPMC10938677 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature