With the new EU Regulation on clinical trials due to take effect in 2016, the ramifications on how trials are conducted in Europe could be far-reaching. Clinical Trials Arena Editor Henry Kerali spoke with a leading expert from the European Commission (EC), who says the new measures brought into play will boost clinical research in Europe.
Henry Kerali: What do you feel are the biggest challenges facing the industry in implementing these changes?
European Commission: We feel, and this is supported by the strong support and positive reaction that we had from sponsors (industry, academic and research charities) when we presented the Commission proposal in 2012 and when the regulation was adopted by the European Parliament and Council, that the new Regulation will bring about many advantages for sponsors, be they industry or academic.
HK: What are the implications of EU regulations on the running of global clinical programs?
EC: The new Regulation (which will be directly applicable throughout the EU, contrary to what happens with Directives, which have to be implemented into national legislation) will seriously improve the conditions for conducting multinational clinical trials under the most advanced standards of subject protection and data robustness- in particular, but not exclusively, intra-EU.
HK: How will things change for global sponsors when submitting applications?
EC: The new Regulation introduces some significant measures which will contribute to boosting clinical research in Europe, for example:
- A streamlined application procedure via a single entry point – an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application. No more mountains of papers, to be duplicated for every Member State or even centre where a sponsor plans to conduct a trial;
- A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;
- The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;
- Improved conditions for conducting multinational clinical trials, which are key for rare and serious diseases;
- Strengthened rules on the protection of patients and informed consent;
- More transparency on the conduct and results of the clinical trial, thanks to a compulsory prior registration on the EU portal; and
- The possibility for the Commission to conduct controls in Member States and third countries to ensure the rules are being properly supervised and enforced.