Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

ABSTRACT:

Background

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor.

Methods

A cross-sectional analysis of all interventional clinical trials regist

SUBMITTER: Ramagopalan S 

PROVIDER: S-EPMC4032105 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature