Publication of the new European Regulation on Clinical Trials
Following months of negotiation and revisions of the European Commission’s Proposal for a Regulation on clinical trials, and the repeal of Directive 2001/20/EC, the much anticipated new European Regulation on Clinical Trials was finally published in the Official Journal of the European Union on 27th May. The European Council and Parliament reached an agreement in December 2013 before the Regulation was formally adopted last April. Under the new Regulation, multinational clinical trials will be easier to conduct. The new rules will facilitate cross-border collaboration for larger clinical trials, essential for research on rare diseases.
For years, patients, researchers and the industry have expressed dissatisfaction with the restrictive rules of former Clinical Trials Directive 2001/20/EC. Administrative burden, regulatory requirements and increasing fees have resulted in a marked 25% decline in clinical trial numbers conducted in Europe over the past several years. Under the new Regulation, applicants throughout the EU are required to submit a set of uniform documents for clinical trial authorisation. Applications will be processed via a single clinical trial approval system to ensure a single outcome per country, thus avoiding multiple applications for trials in different member states, and reducing fees and time for application approval. The European Commission estimates that the new rules could save researchers up to €800 million a year.
The new regulatory requirements will be adapted according to the level of risk patients are exposed to during a trial. The Regulation thereby introduces the concept of ’low-intervention clinical trial’, for instance for studies comparing already authorised medicines. Another major objective of the Regulation is to increase transparency. All results, positive and negative, will have to be published in a publicly-accessible database, reflecting demands from initiatives such as AllTrials. OrphaNews kept a close watch on EMA's Work Programme 2014 for data sharing and transparency via a publicly-accessible database throughout April this year. Finally, while individual countries will continue to constitute their own Ethics Committees for the assessment of clinical trials, the Commission reserves the right to monitor EU and non-EU countries in order to ensure rules are uniformly enforced and compliant with EU requirements in the case of trials conducted outside Europe.
The new Regulation will come into effect in mid-2016 at the earliest. For the rare disease community, the Regulation’s support for rapid and in-depth application assessment for clinical trials on orphan drugs is encouraging. Expected benefits of the new regulation will therefore have to be patiently awaited. But many hope that the new Regulation will translate into increased numbers of clinical trials across Europe, for both common and rare diseases.
Consult the EMA press release
In a recent turn of events, the EMA announced last Thursday that it would modify data sharing rules. The announcement came following pressure from European ombudsman Emily O’Reilly, AllTrials Campaign in an open letter to EMA director Guido Rasi, the European Consumers Organisation (BEUC), the European Association of Hospital Pharmacists and GIMBE. The EMA will allow researchers to download, save and print clinical trial data for non-commercial use, a development on the previous proposed draft which limited researchers to on-screen data consultation only. While researchers welcome this draft amendment, they and Ms. O'Reilly remain concerned about the terms of use and redaction policies which would give clinical trial sponsors control over the data they publish. The new rules are expected to be effective from 1st October 2014.