Current status of the Clinical Trials Regulation

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HemAffairs Article #2 – June 2019

In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable. What is the aim of the ‘new’ regulation, what issues does it address, and why was its application delayed.

1. What is the aim of the ‘new’ regulation?

The Clinical Trials Regulation is aimed at harmonizing the requirements for all clinical trials in Europe and streamlining clinical trial authorization processes.

  • Harmonization: The previous rules were adopted as a directive, which means Member States can, to some extent, interpret and adapt the law. The new rules have been adopted as a regulation, which no longer leaves room for national interpretation. As a result, the CTR should be implemented the same way in all Member States. Note that the regulation entered into force in 2014 and was supposed to apply no later than May 2016; a missed deliverable.
  • Authorization: The CTR harmonizes clinical trial requirements throughout the EU by establishing a new EU electronic portal – the Clinical Trials Information System (CTIS). This tool is a centralized portal and database developed and maintained by the European Medicines Agency (EMA) in collaboration with the European Commission and EU Member States. It streamlines electronic submission and the assessment process for clinical trials conducted in various Member States. According to EMA, the tool will increase efficiency of trials and avoid duplication.

2. Why the need for a new regulation?

The new regulation was initiated to increase the number of clinical trials in the EU. Not without reason; the number of applications for clinical trials authorization in the EU decreased by 25% between 2007 and 2011. The old directive – the Clinical Trials Directive – has been criticized because of its bureaucratic tendency. While policymakers and regulators aimed to ensure ‘good clinical practice’, their endless administrative demands do not work out effectively in real life. Researchers are drowning in paperwork and patients struggle with excessive question forms. In the end, the excessive bureaucratic demands defeat its purpose – ‘facilitate clinical trials, stimulate research on medicines for rare diseases and improve the life of patients’.

The new regulation aims to improve collaboration, information-sharing and decision-making between and within Member States, increase transparency of information on clinical trials, and set safety standards for all participants in EU clinical trials. Ideally, it should become easier to conduct clinical trials in the EU, putting the EU back on the map as a progressive research environment. That, according to the European Commission, is in the best interest of the EU and patients: without clinical trials, no new medicines, and no progress in developing treatments for patient with rare diseases.

Whether the new regulation will actually improve the number of clinical trials in the EU and, by extension, the quality and the life of patients, remains to be seen.

3. Why has the CTR not been enforced yet?

EMA, which was given responsibility for the EU Clinical Trial Portal and Database, originally planned to launch the tool by December 2015. However, due to technical difficulties, the system's go-live date has been postponed several times.

According to the latest news from EMA, testing and key bug fixing took place in the spring of 2019 and the system is now being prepared for audit. EMA’s aim is to go live before the end of the year. Once the electronic portal is fully functional and the European Commission has given its approval, it takes six months for CTR to become applicable. Time is ticking.

Last Updated on Tuesday 16 July 2019.