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EU must reform clinical trial regulation, warn medical research bodies

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d6215 (Published 28 September 2011) Cite this as: BMJ 2011;343:d6215
  1. Susan Mayor
  1. 1London

Medical research organisations are urging the European Union to review the regulation of clinical trials because they say that excessive bureaucracy is hampering research into new treatments without enhancing the safety of patients.

Sixteen research organisations, including the European Organisation for Research and Treatment of Cancer, Germany’s KKS Network of Clinical trials in Germany, and the UK Medical Research Council, have sent a joint statement to the European Commission and members of the European parliament. It outlines how the European Clinical Trials Directive—which sets out the legal requirements for conducting clinical trials throughout the European Union—should be revised to streamline the process of approval of clinical trials.

The Clinical Trials Directive 2001/20/EC …

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