Clinical trial transparency: study gives pharmaceutical industry good marks but calls for further improvements

Wed, 2017 / 10 / 25

A new study published by the lobby group AllTrials, chaired by the British physician and co-founder Ben Goldacre, investigated the policies on clinical trial transparency of 42 major pharma companies worldwide. The results of the study were overall positive concludes with remaining room for progress.

Separately, the study analyzed policies of, inter alia, the top 23 pharmaceutical companies by sales and found that 21 companies (91%) are committed to register all trials and 22 of them (96%) are declaring to share summarized results with the public while at the same time are overwhelmingly reluctant to define specific timelines when to disclose the data: this results in an overall time to publication of more than a year. In addition, trials on unlicensed medicines or off-label uses were merely released by 6 companies (26%).

„We found examples at the extremes of good and bad practice concerning the disclosure of clinical trials“, said Goldacre and adds that “pharmaceutical companies should make clear, simple and consistent policies on what they will and will not share while complying to existing compliance requirements.“

One major remaining concern would be “a lack of policies regarding completed but yet unpublished trials“, according to Síle Lane, co-author of the study. „This issue affects not only today’s patients but has also implications on benefit assessments of new treatments since past studies are the foundation of comparative assessments.“ As a consequence, AllTrials now pursues the objective to identify and publish unreported trials in a large scale over the next two years. The message for the pharmaceutical industry: „anyone who is sitting on an unpublished trial should move quickly to get the results reported, before we do it for you!“

AllTrails requests the pharmaceutical industry to join their campaign and to accomplish the standards of transparency. Regarding this, a “transparency-index” ranking has been published in order to compete with other pharmaceutical companies.

Source: Pharmaceutical companies‘ policies on access to trial data, results, and methods: audit study. In: BMJ 2017;358:j3334

http://www.fiercebiotech.com/cro/bmj-paper-finds-pharma-doing-better-trial-transparency-but-more-to-be-done