Brussels, 31/01/2012 (Agence Europe) - In a declaration, the European Science Foundation (ESF) and the European Medical Research Councils (EMRC) have welcomed the revision of the directive on clinical trials, which the European Commission will soon present, and have formulated a number of recommendations for a quality text that might move towards boosting medical research in the world. The directive on clinical trials dates back to 2001 and sets out basic principles for conducting medical clinical trials and ensuring quality, whilst respecting human rights and dignity. The ESF and EMRC request streamlining procedures, introducing a risk-based approach to authorising clinical trials and ensuring greater harmonisation in the implementation of EU rules at national level. Liselotte Hojgaard, the Chair of the EMRC said: “Balancing these aims with the imperative of maintaining a high level of patient safety is the major challenge facing the revision.”
The 2001 directive radically enhanced the quality of Europe's clinical trials on which patient safety resides, and the main research actors want the revision to preserve that high standard, in line with Europe's 2020 objectives, namely those that boost innovation and improve medical treatments. The EMRC does not question the benefits of the strict regulations for high-risk trials involving experimental medicines for humans, but argues in favour of a sliding scale of requirements depending precisely on the risk involved. In this way low-risk trials or comparative trials could benefit from a less restrictive framework than high-risk trials. Clinical researchers wanting to verify the effectiveness of one already licensed medication over another - aspirin versus paracetamol for example - would not have to fulfil the full gamut of rules. The ESF and EMRC also call for more harmonisation in the adoption of the directive at national level and more co-operation between member states. Currently, there are too many variations and restrictions in the different member states, which makes it impossible to implement clinical trials across the EU. This directive aims to correct this shortcoming. “Excellence in clinical research requires a truly functioning harmonisation,” emphasised Professor Hojgaard. “We urge the Commission, European Parliament and the member states to enact a law that unifies clinical trials in Europe.” (IL/transl.fl)