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. 2013 Jan 18;3(1):e001963.
doi: 10.1136/bmjopen-2012-001963.

Haphazard Reporting of Deaths in Clinical Trials: A Review of Cases of Records and Matched Publications-A Cross-Sectional Study

Free PMC article

Haphazard Reporting of Deaths in Clinical Trials: A Review of Cases of Records and Matched Publications-A Cross-Sectional Study

Amy Earley et al. BMJ Open. .
Free PMC article


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 records; (2) how often total deaths can be determined per arm within a results record and its corresponding publication and (3) whether counts may be discordant.

Design: Registry-based study of clinical trial results reporting.

Setting: results database searched in July 2011 and matched PubMed publications.

Selection criteria: A random sample of results records. Detailed review of records with a single corresponding publication.

Main outcome measure: records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between records and corresponding publications.

Results: In 500 randomly selected records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27).

Conclusions: Deaths are variably reported in records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.


Figure 1
Figure 1
Reporting of number of deaths by data module in 123 records.
Figure 2
Figure 2
Consistency of death in matched pairs in (A) those with number of deaths in and (B) those without any information on death numbers in

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