European drug agency backtracks on plan to give researchers access to clinical trial reportsBMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g3432 (Published 21 May 2014) Cite this as: BMJ 2014;348:g3432
- Ingrid Torjesen
The European Medicines Agency has watered down its plans for allowing public access to clinical trial reports as part of its drive towards greater transparency, angering researchers and the European ombudsman.
In addition, the draft terms impose strict confidentiality requirements and wide restrictions on the use of the data.
A further draft document on redaction principles, also seen by The BMJ, outlines the range of information that the EMA would be able to withhold “where disclosure may undermine the economic or competitive position of the owner of the information.”
The agency’s change …
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