Reporting of safety results in published reports of randomized controlled trials.

Département d'Epidémiologie, Biostatistique, et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Université Denis Diderot, INSERM U738, Paris, France.
Archives of internal medicine (Impact Factor: 13.25). 10/2009; 169(19):1756-61. DOI: 10.1001/archinternmed.2009.306
Source: PubMed

ABSTRACT Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant. Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs).
We searched the MEDLINE database for reports of RCTs published from January 1, 2006, through January 1, 2007, in 6 general medical journals with a high impact factor. Data were extracted by use of a standardized form to appraise the presentation of safety results in text and tables.
Adverse events were mentioned in 88.7% of the 133 reports. No information on severe adverse events and withdrawal of patients owing to an adverse event was given in 27.1% and 47.4% of articles, respectively. Restrictions in the reporting of harm-related data were noted in 43 articles (32.3%) with a description of the most common adverse events only (n = 17), severe adverse events only (n = 16), statistically significant events only (n = 5), and a combination of restrictions (n = 5). The population considered for safety analysis was clearly reported in 65.6% of articles.
Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs.


Available from: Philippe Ravaud, Jun 07, 2015
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Randomized controlled trials (RCTs) are known to provide the most reliable evidence on intervention. However, RCTs are often conducted and reported incompletely and inadequately, making readers and reviewers unable to judge the validity and reliability of the trials. In this article, we consider the statistical and methodological issues involved in reporting on RCTs, particularly in relation to the objectives, designs, and commencements of trials. This paper deals with the various issues that should be considered in presenting RCTs, and suggests checklists for reporting on them. We expect that these checklists will remind readers and reviewers to evaluate manuscripts systematically and comprehensively, making those manuscripts more transparent and reliable.
    Korean journal of anesthesiology 04/2015; 68(2):106-15. DOI:10.4097/kjae.2015.68.2.106
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose to release, the amount of published information regarding drug safety, the effectiveness of postmarket surveillance systems in recognizing and reporting adverse drug reactions, and the structure of DRAs such as the United States Food and Drug Administration and its equivalent in other countries. This commentary will look at each of these issues in order to highlight the problems in the current approach to drug safety and finally indicate how some of these deficiencies should be addressed.Please see related article:
    BMC Medicine 12/2015; 13(1):27. DOI:10.1186/s12916-015-0270-2 · 7.28 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Many of the issues with using data from clinical trials and observational studies for economic evaluations are highlighted in the case of chemotherapy side effects. We present the results of an observational cohort study using linked administrative data. The chemotherapy side effects identified in the administrative data are compared with patient self-reports of such events. The results of these comparisons are then used to guide a discussion of the issues surrounding the use of administrative data to identify clinical events for the population of economic models. Although the advantages of easy access and generalizability of the results make administrative data an attractive option for populating economic models, this is not always possible because of the limitations of these data.
    Expert Review of Pharmacoeconomics & Outcomes Research 12/2014; 15(2). DOI:10.1586/14737167.2015.990888 · 1.87 Impact Factor