Editorials

Big strides in Europe towards clinical trial transparency

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6276 (Published 20 October 2014) Cite this as: BMJ 2014;349:g6276
  1. Trish Groves, deputy editor
  1. 1The BMJ, London WC1H 9JR, UK
  1. tgroves{at}bmj.com

The EMA, EU, and UK HRA usher in an age of evidence enlightenment

Two and half years ago several of Europe’s medicines regulators proposed that complete trial data on all drugs approved in the EU should be made publicly available in the best interests of public health.1 About time too, thought many advocates of research transparency, but would they really do it? Now we know that they will, despite attempts to derail their plans.2

The European Medicines Agency (EMA) decided on 2 October that, for all new centralised drug marketing authorisations submitted after 1 January 2015, it will provide public access to the core content of clinical study reports and will allow researchers to download and use the reports for further analyses.3 Members of the public will have to register to read the reports on screen, while academics and researchers must register and also provide proof of identity. The same policy will apply from 1 July 2015 to applications to vary marketing—submitted, for example, to seek authorisation for new indications of already approved drugs. At some point in the future, after further debate on the ethical and technical challenges, the agency intends to also provide access to the anonymised individual patient data from its …

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