The way clinical trials are conducted and reported in the European Union will undergo a major change when the Clinical Trial Regulation comes into force in 2019.
The way clinical trials are conducted and reported in the European Union will undergo a major change when the Clinical Trial Regulation comes into force in 2019. The regulation combines the assessment and supervision processes for clinical trials throughout the European Union, via an EU portal and database. The European Medicines Agency (EMA) will set up and manage the portal and database, in collaboration with the Member States and the European Commission.
The goal of the Clinical Trial Regulation EU No. 536/2014 is to create an environment that is beneficial to conducting clinical trials in the European Union while maintaining the highest standards of safety for participants and increased transparency of trial information. The regulation will require consistent rules for conducting clinical trials throughout the European Union, and will stipulate that information on the authorization, conduct, and results of each clinical trial carried out in the EU be made publicly available.
This new regulation seeks to increase the efficiency of all trials throughout the European Union, with the greatest benefit for those conducted in multiple member states, by seeking to foster innovation and research while helping to avoid unnecessary duplication.
The EU clinical trial portal and database will be a single entry point for submitting clinical trial information, and the EMA will make information stored in the database publicly available (subject to transparency rules). The EMA published the functional specifications for the EU portal and database to be audited in December 2014, following a public consultation.
Although the regulation was adopted and entered into force in 2014, the timing of its implementation depends on confirmation of “full functionality” of the EU portal and database through an independent audit. Development of the portal is currently making progress toward completion; a partially-completed version of the system has been undergoing user-acceptance testing by representatives of the European Commission, member states, academics, the pharmaceutical industry, and contract research organization (CRO) associations, while technical testing and further development continue.
The feedback from user-acceptance testing is being consolidated and analyzed while engineers fix small glitches found throughout testing, and the development of the auditable version is moving forward.
The audit is scheduled to be carried out in 2018, and the regulation will become applicable 6 months after the European Commission publishes notice of the confirmation of full functionality of the portal.