European Commission proposes new rules on conducting clinical trials
On 17 July, the Commission published a new Regulation on clinical trials, which will replace the 2001 Clinical Trials Directive. The intention of this Regulation is to boost clinical research by simplifying the rules for conducting clinical trials. With over 20 billion Euros of investment per year in the EU clinical trials research makes a significant contribution to the EU’s growth policy.
Once implemented, the new measures will 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.
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.
- Ensure that the rules are being properly supervised and enforced.
The legislative proposal will now be discussed in the European Parliament and in the Council and is expected to come into effect in 2016.
EuGMS will carefully analyse the proposal to see whether its proposals were taken into account and work with the European Parliament to ensure that the new rules will facilitate the inclusion of older subjects in clinical trials.
For more information on clinical trials:
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm
