Letters Open data for all current drugs

We need access to data on all clinical trials, not just some

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e8001 (Published 26 November 2012) Cite this as: BMJ 2012;345:e8001
  1. Beate Wieseler, head, Drug Assessment Department1,
  2. Natalie McGauran, researcher, Communications Department1,
  3. Thomas Kaiser, head, Drug Assessment Department1
  1. 1Institute for Quality and Efficiency in Health Care, 50670 Cologne, Germany
  1. beate.wieseler{at}iqwig.de

Although the BMJ and GlaxoSmithKline’s initiatives are highly commendable,1 these initiatives would not completely solve the problem of reporting bias. Comprehensive access to clinical trial data can be ensured only by the routine release of all clinical study reports (CSRs) after drug approval. In 2010, the European Medicines Agency (EMA) introduced a new policy on the release of clinical trial data submitted to the agency.2 However, the data format is …

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