Editorials

Clinical trial data: get them while you can

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g63 (Published 06 January 2014) Cite this as: BMJ 2014;348:g63
  1. Peter Doshi, associate editor,
  2. Trish Groves, head of research,
  3. Elizabeth Loder, clinical epidemiology editor
  1. 1BMJ, London WC1H 9JR, UK
  1. pdoshi{at}bmj.com

The window into the European Medicines Agency’s archives may not be open for long

Third party access to clinical trial data seems an obvious and uncontroversial core requirement for the production and dissemination of trustworthy medical evidence. For the past four years, the BMJ has actively campaigned to compel greater transparency of clinical trial data. Anybody following this matter will know that movement is occurring at many levels and involves a large number of actors including industry, politicians, regulators, academia, and medical journals. The debate encompasses which data should be shared and with whom, when, and under what conditions. However, even the most keen observers will probably be uncertain about just what has happened, is happening, and where things will eventually land.

One development to watch out for in 2014 will be the progress of the European Union’s proposals on clinical trial regulation.1 2 Other developments include the European Medicines Agency’s (EMA) future policy on publication and access to the clinical trial data that underpin marketing authorisation decisions,3 and the US Institute of Medicine’s (IOM) consensus study on responsible sharing of clinical trial data.

The IOM is expected to release an interim report in January 2014, followed by public consultation and a final report in about a year’s time.4 If the committee endorses onerous restrictions on …

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