The Clinical Trials Directive (PDF) was made to bring all clinical trials conducted within the EU under the same regulations and aims to ensure:
- The protection of the health and safety of clinical trial participants
- The ethical soundness of the clinical trial
- The reliability and robustness of data generated in clinical trials
- Simplification and harmonisation of the administrative provisions governing clinical trials in order to allow for cost-efficient clinical research.
But since its introduction there have been difficulties in implementing the regulations and concerns that it may be leading to unnecessary delays and escalating costs.
In January 2010 the European Commission held a public consultation investigating the impacts of the European Clinical Trials Directive – 'Assessment of the functioning of the Clinical Trials Directive 2001/20/EC'.
AMRC responded to this consultation.
What has happened now?
The Commission has published a summary of the responses to this consultation.
For reference, the original consultation is also available (PDF).
The Comission has also updated the roadmap (PDF) planning the review of the directive.
The Commission is now producing an impact assessment report informed by this consultation. This is due to be published in the course of 2010-11.
Updated April 2010