Intended for healthcare professionals

Observations Open Data Campaign

Open letter: European Medicines Agency should remove barriers to access clinical trial data

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3768 (Published 06 June 2014) Cite this as: BMJ 2014;348:g3768
  1. Ben Goldacre, research fellow in epidemiology, London School of Hygiene and Tropical Medicine,
  2. Fiona Godlee, editor in chief, The BMJ,
  3. Carl Heneghan, director, Centre for Evidence based Medicine, Oxford,
  4. David Tovey, editor in chief, Cochrane Library,
  5. Richard Lehman, general practitioner, Oxfordshire,
  6. Iain Chalmers, coordinator, James Lind Initiative,
  7. Virginia Barbour, medicine editorial director, PLOS,
  8. Tracey Brown, managing director, Sense About Science
  1. Correspondence to: All Trials campaign, c/o Sense About Science, 14a Clerkenwell Green, London EC1R 0DP, UK alltrials{at}senseaboutscience.org

In an open letter to Guido Rasi, director of the European Medicines Agency, the AllTrials campaign urges the EMA to revise its trial data policy or risk losing the trust of patients and healthcare professionals

Dear Professor Rasi

Hundreds of supporters of the AllTrials campaign (alltrials.net) contributed last year to the European Medicines Agency’s consultation on its draft policy “Publication and access to clinical-trial data.” We welcomed the EMA’s proposals, which would have seen clinical study reports published proactively and openly, in line with an agency policy that the information in those reports should not generally be considered commercially confidential. We are now concerned that the most recent draft of the policy (EMA/240810/2013), as shared with some stakeholders at meetings this month, introduces barriers that will make it all but useless to independent researchers.

We understand that there are four areas of particular concern:

  • Clinical study reports (CSRs) will be available for viewing only on screen and cannot be saved, downloaded, printed, copied, annotated, or shared in any way. This will make it nearly impossible for researchers to usefully scrutinise the documents. CSRs often contain thousands of pages of complex information. Research teams need to …

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