European Parliament publishes approved amendments to new Clinical Trials Regulation

The European Parliament has published an update on the progress of the new Clinical Trials Regulation.

This follows its reading in the European Parliament’s Committee on the Environment, Public Health and Food Safety, which saw voting on over 700 amendments (many considered in groups) to the European Commission’s original proposal. The latest report covers 125 amendments that were approved by the committee, including a brief justification in each case. The update also includes 17 amendments from the Committee on Civil Liberties, Justice and Home Affairs.

Among some of the most interesting amendments approved at this stage, the report includes:

  • More explicit mention of Ethics Committee examination of research proposals, making explicit mention of the Declaration of Helsinki (but not specifying any particular version)
  • Replacing the term “low-intervention clinical trial” with “low-risk clinical trial”, and adopting the OECD categorisations, considering categories A and B(1) to be low-risk clinical trials
  • Encouraging Member States to exempt academic sponsors from fees for, eg, study applications, inspections etc.
  • Assigning a Universal Trial Registration Number (UTRN) to enable greater traceability from application to publication.
  • Encouraging the European Commission to facilitate greater cooperation between Ethics Committees in different Member States
  • Measures to increase transparency. In particular, one amendment states “in general the data included in clinical study reports should not be considered commercially confidential once a marketing authorisation has been granted
  • Enable a more risk-adaptive approach, with one amendment stating that “monitoring should be adapted to the nature of the trial and focus on mitigating the key risks

The next procedural stage for the Regulation is scheduled for November 18th 2013, when it will be considered by a plenary session of the European Parliament.

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