The European Medicines Agency’s plans for sharing data from clinical trialsBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2961 (Published 08 May 2013) Cite this as: BMJ 2013;346:f2961
- Trish Groves, deputy editor ,
- Fiona Godlee, editor in chief
- 1BMJ, London WC1H 9JR, UK
- ; twitter/trished
A bold plan by the European Medicines Agency (EMA) to prospectively release anonymised clinical trial data on drugs has suffered a potentially serious setback. Cases brought by biopharmaceutical companies AbbVie and InterMune have led to an interim ruling from the General Court of the European Union ordering the agency not to release relevant documents on request until final judgment has been made.1 2 It is not yet clear whether this interim ruling will derail the agency’s much wider plan to publicly release the anonymised patient level trial data on all drugs it approves from January 2014.3 If the final judgment does block this plan, a great opportunity to complete the evidence base on drugs and to improve human health will have been lost.4 The risk to the public interest and to patients has prompted the BMJ and the BMA to join forces in support of the EMA. The two organisations are requesting leave from the court to intervene in the case brought by AbbVie.
Getting full access to data from trials of drugs and medical devices is not, as some who oppose the move suggest, primarily about trying to uncover misconduct or encourage patients to seek recompense for harms, although these actions may sometimes be necessary and valuable. Nor are calls for open clinical trial data simply academic. The main reasons for sharing full clinical trial data are scientific and ethical, with the interests of prescribers and …