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Audit of pharma policies on the reporting of data from clinical trials

Pharma policies on data reportingIn a new paper published in the BMJ, Ben Goldacre and co-workers suggest that pharmaceutical companies have variable policies on the reporting of clinical trials. While some have clear procedures in place for making their data available, others have policies that are more ambiguous. This matters because evidence suggests that some clinical trials still go unpublished, and yet complete and transparent reporting is essential for allowing doctors, medical regulators and patients to evaluate the safety and efficacy of drugs.

In the study, which was summarised in a blog post on Fierce Biotech and discussed in the BMJ Podcast, Goldacre et al. audited the reporting policies of 42 pharmaceutical companies. According to the study, 40 of the companies (95%) had made their policies freely available online. Of the 23 largest companies by global sales, 21 (91%) had committed to registering all trials, and 22 (96%) promised to make all results publicly available in summary form. However, Goldacre et al. found that few companies included specific timelines for when they would disclose this information, and only six (26%) had policies for reporting trials of unlicensed drugs or off-label uses. Many policies featured ambiguous wording, for example referred to ‘all trials’ but then subsequently introduced caveats. The study suggested that smaller companies may make fewer transparency commitments than their larger counterparts.

Lead author Ben Goldacre is one of the co-founders of the AllTrials initiative, which is campaigning for all clinical trials, including past trials, to be registered; for all results to be reported in summary form within 12 months of trial completion, and for all Clinical Study Reports to be made publicly available. The AllTrials petition has so far been signed by more than 90,000 people and by more than 700 organisations.


Summary by Louisa Lyon, DPhil from Aspire Scientific



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