Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC

The European Commission issued in October 2009 a public consultation paper 'Assessment of the functioning of the "Clinical Trials Directive" 2001/20/EC' (CTD). The deadline for responding was 9 January 2010.

The Commission has received 106 responses; 60 responses came from hospitals, investigators and 'non-commercial'/'academic' sponsors, 22 from the pharmaceutical industry and contract research organisations (CROs), 10 from national competent authorities (NCAs), 6 from Ethics Committees (ECs), 3 from patient organisations and 5 from other entities and individuals.

The responses have now been published by the Commission in a paper summarising the responses to the public consultation document. In doing so, it not only reflects the majority views, but aims to give a 'snapshot' of the range of responses.

The public consultation was welcomed by practically all respondents, however many respondents doubted that the CTD had brought about improvements in terms of safety and rights of participants. On the other hand, several respondents stressed that the quality of clinical trials in terms of data reliability had improved. Also, respondents highlighted that the CTD had led to more communication between academia and industry and amongst academia and that, following the implementation of the CTD, supervision and communication of the sponsor with the investigator was more continuous. Also the clearer separation of responsibilities was highlighted as a benefit.

The detailed responses to the tasks

  • Multiple and divergent assessment of the clinical trials
  • Application
  • Streamlined authorisation
  • Ethics committees
  • Inconsistent implementation of the CTD
  • Making the CTD into an EU regulation
  • Insufficient risk differentiation
  • Adaptation to practical requirements
  • Revision of guidelines
  • Exclusion of academic research from the scope of the CTD
  • Paediatric clinical trials
  • Emergency trials
  • Clinical trials in third countries

can be found in the document.

Summarised by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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