Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013 Jan 18;3(1):e001963.
doi: 10.1136/bmjopen-2012-001963.

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

Affiliations
Free PMC article

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

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

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

Results: In 500 randomly selected ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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.

Figures

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

Similar articles

See all similar articles

Cited by 7 articles

See all "Cited by" articles

References

    1. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med 2005;142(12 Pt 2):1090–9 - PubMed
    1. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001;285:437–43 - PubMed
    1. Food and Drug Administration Code of Federal Regulations Title 21. 21 CFR 312.33(b)(3)—Annual Reports. 2012. Ref Type: Bill/Resolution
    1. Food and Drug Administration. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule. Fed Regist 2010;75:59935–63 - PubMed
    1. Sherman RB, Woodcock J, Norden J, et al. New FDA regulation to improve safety reporting in clinical trials. N Engl J Med 2011;365:3–5 - PubMed

LinkOut - more resources

Feedback