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A recently published paper in PLOS Medicine has investigated how adverse event data from clinical trials are summarised and consequently reported in published papers - click here for the open-access article.

Using the adverse event data reported in Clinical Study Reports (CSRs) of a marketed drug and comparing this to the corresponding published paper, the study authors were able to detect differences between the two. Their findings led them to conclude that there was potential bias in the reporting of harms in the published papers.

The CSR is a document generated by pharmaceutical companies and submitted to the European Medicines Agency (EMA) as part of the drug approval process and it is not usually publicly available (see interview with the author here, where they discuss the study findings and also the difficulties in obtaining the CSRs used for this study). On the other hand, the published paper is publicly available and often the only source of evidence on which prescribing habits and policy is determined. Differences between harms reported in the CSR and the published paper call into question how and when decisions are made on the handling and analysis of this data and the resulting implications.

If you have an opinion on this paper and its results, why not post it below? Do you think more guidance in the collecting, handling and analysis of harms data is needed? Is standardisation/harmonisation the answer? Let us know your thoughts!