Dr Peter Arlett
Head of Data Analytics and Methods, the European Medicines Agency
The new European Clinical Trials Regulation, which came into application on 31 January 2022, has rung in a new era for clinical trials in the EU.
Over the next three years, the new regulation is going to unify the EU into one research space where the same rules and processes for the submission, evaluation and supervision of clinical trials apply, no matter where in the Union the trial takes place.
Creating better clinical trials
It will significantly reduce administrative burden and allow both sponsors and regulators to channel their efforts towards bigger, better, more impactful clinical trials that generate robust evidence. This will support the translation of scientific innovation into public health gains for patients.
In the past, trial sponsors had to submit clinical trial applications separately to the national regulator and ethics committees in each EU Member State where they planned to run a trial. Under the new rules, sponsors will be able to use one single process to apply for the authorisation of a clinical trial, no matter where they are located and with which national competent authorities or ethics committees they are dealing.
Advantages of multinational trials
The benefits, particularly for multinational trials, are substantial: sponsors can now apply for authorisation of a trial in up to 30 countries (27 EU Member States plus Iceland, Liechtenstein and Norway) at the same time by submitting one application to the relevant authorising bodies. These bodies will carry out one single assessment of the application dossier on which all other Member States will base their authorisation of the trial.
It will significantly reduce administrative burden and allow both sponsors and regulators to channel their efforts towards bigger, better, more impactful clinical trials that generate robust evidence.
Clinical trial workspaces streamline processes
The unprecedented regulatory alignment for clinical trials in a region as large as the EU, with its nearly 500 million citizens, is made possible by harmonised and streamlined workflows powered by the Clinical Trials Information System (CTIS).
Maintained by the European Medicines Agency, it provides a dedicated secure workspace for trial sponsors where they can apply for and manage their clinical trials. A similar workspace allows the authorising bodies to assess applications and easily interact with the sponsor and supports fast collaboration and information exchange with other authorities.
The new system not only enables more efficient and streamlined processes. It also includes a publicly searchable database that will radically increase transparency of clinical trials data. The information that will be made available throughout the life cycle of a trial in CTIS is expected to stimulate information sharing and peer learning among researchers, while patients and healthcare professionals will be able to search for trials.
