The pioneers of transparencyBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.g7717 (Published 02 January 2015) Cite this as: BMJ 2015;350:g7717
- Ben Adams, freelance journalist, London
On 1 January 2015 a watershed moment came for clinical trial transparency when a long awaited policy change at the European Medicines Agency came into force. From this date all successful applications to the agency will lead to publication of the relevant trials’ clinical study reports.
The change of policy opens a new era of transparency that has been hard fought for, over many years, by many researchers and a few very committed policy makers.1 It will be followed, in May 2016, by the new European Union Clinical Trials Regulation, which says that the clinical information in clinical study reports should not be considered commercially confidential, thus removing the legal argument that drug companies have used until now to justify withholding large amounts of trial data.
But many battles are still to be fought. For now, the European Medicines Agency can still make restrictions and redactions if it considers data to be confidentially commercial (such as proprietary secrets about the drug molecule), although the regulator has emphasised that this is likely to happen only in a small number of cases.2 And the new legislation will not apply retrospectively to data from drug applications made before 1 January 2015, meaning that the full trial data on the vast majority of the drugs we currently use will still not be available.
However, the fact is that within two years the public and researchers will be able to read, in full, clinical study reports for all newly approved drug trials, whether conducted by industry or academia.
“It’s easy to focus on the hurdles ahead, but let’s stop …