In our last edition we reported on the European Commission's proposal to replace the Clinical Trials Directive (Directive 2001/20/EC) with a new Clinical Trials Regulation).

The House of Commons Science and Technology Committee has now published a report on clinical trials in which it welcomes this proposal, recognising that it will make it easier to conduct trials across the EU, but concludes that more needs to be done to make the UK an easier place to conduct clinical research.

The report recommends that the Government and the MHRA continue engaging at a European level to ensure that the Clinical Trials Regulation is sufficiently clear so as to avoid inconsistencies in its implementation between Member States of the EU and to ensure that when it is introduced the administration of clinical trials in the UK will be pragmatic and proportionate.

The report goes on to state how, while improvements were needed at the European level, there remain several barriers to conducting a clinical trial specifically within the UK which the Government needs to address. The biggest barrier being the fact that clinical trials are subject to approval from each NHS organisation involved.

Increased clinical trial transparency was also recommended with a view to achieving improved patient outcomes, enhanced scientific knowledge and increased public trust in research. The Committee suggests that:

  • l all clinical trials conducted in the UK, and all trials related to treatments used by the NHS are subject to mandatory registration in a WHO-listed primary registry;
  • l summary-level results are made publically available for all trials;
  • l Clincial Study Reports are placed in the public domain once a regulatory decision has been made (with identifiable patient data redacted); and
  • l individual patient-level data is made accessible to specific individuals on a controlled access basis.

The full report can be found at http://www.publications.parliament.uk/pa/cm201314/cmselect/cmsctech/104/104.pdf.

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