Companies Do Not Publish All Adverse Events from Sponsored Clinical Trials

An analysis of published and unpublished adverse events reports from clinical trials shows that much of the adverse event data is not published in peer-reviewed journals. The authors concluded that peer-reviewed journals are not a reliable source for all adverse events identified for a given drug. The authors recommended that interested parties should look at other sources for complete adverse event data, such as presentations at conference or approaching the sponsor for complete clinical study reports. This should not come as a surprise to anyone familiar with the publication policies of journals. All peer reviewed publications have strict limitation on the length of the article and prefer that the authors include only selected data relevant to the point being made. However, the omission of data from publications does not need to be for sinister reasons as the authors seem to indicate. The regulatory review of all data in support of marketing approval applications is always based on the review of complete study reports and not publications. Also, the drug labels are approved by the regulators to assure that all relevant safety information is adequately presented. Anyone looking for complete adverse event information should try to get access to the full study report or at least do a very thorough search to find all pieces of information.