The current Clinical Trial Directive (CTD) rules are over 10 years old and much criticised as they have led to an increase in costs and administrative burden.

In his speech, Commissioner Dalli expressed concern that the number of CTs conducted in Europe has declined significantly, while costs for bureaucracy and resource requirements to handle paperwork have doubled, and delays have increased by 90%. Crucially, he stated that clinical trials are a ’’key contributor to growth and jobs in the area of public health’’ since they imply research and investment, including inward investment from outside the Union. They account for investments of over €20 billion per year in the EU. Hence it was extremely important to create ’’the right regulatory framework’’. To this purpose, Dalli affirmed that the broadest possible involvement of stakeholders would be sought.

EPHA position on Clinical Trials

The recent briefing and policy recommendations by EPHA member Cancer Research UK underlines the main issues in the current CT framework which have led to concerns voiced by patients, researchers and industry, amongst them:

- Burdensome authorisation process for small multi-country trials
- Inflexible assessment system of CT applications
- Global aspects of CTs, e.g. decreased patient protection in third countries due to non-compliance with equivalence rule

Stakeholders are now eagerly awaiting the Commission’s legislative proposal in the hope that it will streamline and simplify administrative procedures. However, the scope of the Directive will not be altered.

The revision will likely take the form of a Regulation, and the proposal is now scheduled for adoption in September 2012. Following last year’s position paper (2011 EPHA policy position on the revision of the Clinical Trials Directive) EPHA will continue to monitor the process and seek clarification on key issues related to the dossier.


For further information

- Clinical Trials - Major Developments, DG SANCO

- Cancer Research UK website

EPHA related articles

- Research organisations launch joint statement on clinical trials
- Clinical Trials Register goes live
- Philippe Juvin MEP hosts a Lunch debate on Clinical Trials
- EPHA Briefing on Cross-border Patients’ Rights Directive

Last modified on March 27 2012.