Reaction to European Medicine Agency’s transparency policy

ClinicalTrialsGlenis Willmott MEP, rapporteur for the Clinical Trials Regulation has commented following the meeting of the European Medicines Agency (EMA) on the publication of clinical trials data.

“I am pleased to see the idea of ‘screen-only’ viewing of clinical trial data scrapped, which was certainly not the kind of user-friendly system I want to see. This was a key concern in my open letter to EMA, and I’m glad they have listened,” said Mrs Willmott.

“However it is still not clear what will eventually be agreed regarding the terms of use for the data, and I will be following EMA’s discussions on this closely. Forcing users into legal agreements with pharmaceutical companies could be very problematic.”

“In April the European Parliament voted almost unanimously for strict new transparency requirements which will require clinical trial data from all trials to be uploaded to a publicly accessible database. Although the law does not come into force until 2016, until then EMA should be working in the spirit of the transparent and user-friendly system that we agreed.”

“Clinical trial data is collected from volunteers who want to further medicine for themselves and others in a similar situation. It should be made publicly available to patients, doctors and researchers to improve treatments, decision making and public trust in medicine.”

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