• Romain Favier and Sabrina Crépin.
• Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, France.
• Clin Trials. 2018 Jun 1; 15 (3): 257-267.

Background/AimsAccurate information on harms arising from medical interventions is essential for assessing benefit-risk ratios. Since 2004, there has been an extension of the Consolidated Standards of Reporting Trials statement for reporting harms data in publications on randomized clinical trials. The objective of our study was to assess the quality of this reporting from academic randomized clinical trials on drugs.MethodsWe searched for articles on randomized clinical trials funded between 2004 and 2008 by the "Programme Hospitalier de Recherche Clinique." We included all published randomized clinical trials that assessed drugs. Harm-related data were extracted and compared with the Consolidated Standards of Reporting Trials Harms extension, and the space in the articles devoted to harms data was measured.ResultsIn total, 37 randomized clinical trials met the inclusion criteria. The median harm score was 9/18. In 73.0% of the randomized clinical trials, the reporting of adverse events was selective. Less than 50% of articles provided information on reasons for drug discontinuation that were related to adverse events. The score and the space allocated to harms were higher in antineoplastic and immunomodulating drugs randomized clinical trials, while the median proportion of the space in the results section allocated to harms was 16.8%. In 67.6% of the articles, the space allocated to the authors' list and affiliations was greater than the space in the results section allocated to descriptions of harms. No significant improvement in the score or the space allocation was observed during the study period.ConclusionReporting of harms in French academic drug randomized clinical trials is suboptimal; moreover, this shortcoming is a critical barrier to evaluating the benefit-risk ratio of drug randomized clinical trials. Thus, the authors should be encouraged to adhere to the Consolidated Standards of Reporting Trials Harms extension.

20 keywords...

hide…