The Clinical Trials Directive - a summary

The EU Clinical Trials Directive came into force in the UK on 1 May 2004.

It applies to the vast majority of clinical trials of medicinal products, and no distinction is made between commercially-funded drug trials and non-commercial/academic research. University and NHS research projects are therefor equally subject to its influence as big Pharma-run trials.

In summary:

• A trial may only be started in a Member State of the EU if it has been authorised by the relevant Competent Authority in that Member State (in the UK, this is the MHRA) and has been given a favourable opinion by an ethics committee.
• Each trial must have an identified sponsor who is responsible for trial initiation (including obtaining authorisation), management, conduct and pharmacovigilance.
• To provide public health protection, the CTD sets out the requirements for obtaining informed consent from participants and, in particular, sets out the porcess that must be followed in relation to specific vulnerable groups.
• Both EMEA and national regulatory authorities will conduct mandatory GCP inspections. The findings from these inspections, together with details of each authorised trial, will be available for all other Member States' regulatory authorities to see on a new European database for clinical studies.
• Failure to comply with certain aspects of the CTD may constitute a criminal offence and carry a prison sentence of up to two years, together with a fine.

Make no mistake; the introduction of the CTD is not merely an extension of existing regulations. Anyone involved in conducting or sponsoring clinical trials needs to be aware of the new responsibilities imposed.