Intended for healthcare professionals


Deficiencies in proposed new EU regulation of clinical trials

BMJ 2012; 345 doi: (Published 20 December 2012) Cite this as: BMJ 2012;345:e8522
  1. Peter C Gøtzsche, director
  1. 1Nordic Cochrane Centre, Rigshospitalet, Department 7811, DK-2100 Copenhagen Ø, Denmark
  1. pcg{at}
  • Accepted 11 December 2012

The EU Clinical Trials Directive has been heavily criticised for being bureaucratic, confusing, and leading to a decline in the number of trials conducted in Europe. Although new proposals for regulation are much better, Peter Gøtzsche argues improvements are still needed for patient safety, rational use of drugs, and research planning

The new European Union Regulation on Clinical Trials applies to all drug trials in the EU.1 Due to be finalised early in 2013, it will replace the much criticised Clinical Trials Directive. It aims to simplify the process for application and approval of trials and make it more uniform throughout the EU. It also includes a lighter regime for low risk trials—for example, those using licensed medicines. It contains much good sense, but there are still deficiencies in providing access to information and protection to patients. Ahead of a major discussion of the proposed regulation in the European parliament, I outline ways in which the regulation could be strengthened further.

Public access to information

Applications to conduct clinical drug trials will be submitted through a single EU portal, from where the relevant national authorities will access and process the applications. All the application information, and subsequently results and data, will be publicly accessible unless confidentiality is justified to protect personal data or commercially confidential information.

This should not be a problem. Under the current proposal the EU database will contain no personal data on trial participants, and the European ombudsman has declared that there is no commercially confidential information in trial protocols or clinical study reports.2 Furthermore, the interests of public health and the citizens’ right to know should override any invocation of commercial confidentiality. Patients volunteer for research to benefit society and future patients, not to benefit a particular drug company.

Summary results must be reported to the EU database …

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