Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

ABSTRACT:

Background

ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.

Purpose

To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.

Data sources

ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.

Study selection

10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.

Data extraction

One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.

Data sy

SUBMITTER: Hartung DM 

PROVIDER: S-EPMC4617780 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature