Faced with a decrease of 25 per cent in the number of clinical trials conducted in teh EU between 2007 and 2011, the EU Commission recently proposed simplifying the rules for conducting clinical trials. Aimed at boosting clinical research in Europe, the proposals once implemented are expected to speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data. The measures will also better differentiate the obligations according to the risk-profile of the trial, and improve transparency including on trials done in third countries.
With over 20 billion euros of investment per year in the EU, clinical trials makes a significant contribution to the growth policy of the Europe 2020 agenda. After discussion in the European Parliament and in the Council, the July 17 legislative proposal is expected to come into effect in 2016.
Expanding on the rationale behind these proposals, John Dalli, European Commissioner for Health and Consumer Policy, said, “Patients in Europe should have access to the most innovative clinical research. Clinical trials are crucial for developing new medicines and improving existing treatments. This is why (this) proposal significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data. 800 million euros per year could be saved in regulatory costs and boost research and development in the EU, thus contributing to economic growth.”
The proposed Regulation, once adopted, will replace the ‘Clinical Trials Directive’ of 2001. The release noted that while it ensured high level of patient safety, its divergent transposition and application led to an unfavourable regulatory framework for clinical research, resulting in 25 per cent decrease in clinical trials conducted between 2007 and 2011.