EU Commission proposes revamp of clinical trial rules

Faced with a decrease of 25 per cent in the number of clinical trials conducted 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.”

According to a press release from the EU Commission, the proposed Regulation, once adopted, will replace the ‘Clinical Trials Directive’ of 2001. It has ensured high level of patient safety, but its divergent transposition and application led to an unfavourable regulatory framework for clinical research, thus contributing to a decrease of 25 per cent of clinical trials conducted in the period between 2007 and 2011: in 2007, more than 5000 clinical trials were applied for in the EU while by 2011 the number had dropped to 3800.

The new legislation proposed by the Commission will take the form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. In particular, it will make it easier to conduct multinational clinical trials in Europe.

Some concrete proposals are:
• An authorisation procedure for clinical trials which will allow for a fast and
thorough assessment of the application by all Member States concerned and which
will ensure one single assessment outcome.
• Simplified reporting procedures which will spare researchers from submitting
largely identical information on the clinical trial separately to various bodies and
Member States.
• More transparency on whether recruitment for participating in a clinical trial is
still ongoing, and on the results of the clinical trial.
• The possibility for the Commission to conduct controls in Member States and
other countries to make sure the rules are being properly supervised and


EP News Bureau

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