Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

ABSTRACT:

Context

A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported.

Objective

To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant.

Design

Registry-based study of clinical trial results reporting.

Setting

ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications.

Selection criteria

A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication.

Main outcome measure

ClinicalTrials.gov records report

SUBMITTER: Earley A 

PROVIDER: S-EPMC3549200 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature