Regulation (EU) No 536/2014, known as the Clinical Trial Regulation (CTR), comes into effect in the European Union from 31 January 2022. The new Clinical Trials Information System (CTIS), a new central EU portal and database for clinical trial information that forms the backbone of the CTR, also goes live today.
The CTR represents a significant change in the way clinical trials are conducted in Europe, aiming to support innovation and product development for patients, strengthen standards of safety in clinical trials and increase transparency of clinical trial information.
The CTR harmonises the submission, assessment and supervision of clinical trials in the EU. In the past, sponsors had to submit clinical trial applications separately to regulatory authorities and ethics committees in each country to gain approval to run a clinical trial, and registration and posting of results were also separate processes. Sponsors can now use CTIS to apply for authorisations in up to 30 EU/EEA countries at the same time.
Information on the authorisation, conduct and results of each clinical trial carried out in the EU will be made publicly available. This will increase the efficiency and transparency of all trials in Europe, aiming to foster innovation and research, while helping to avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials. The wider exchange of information is intended to broaden knowledge about new medical treatments, benefitting scientific research and public health. A publicly available website will allow patients to access information about ongoing clinical trials in Europe.
Additionally, the streamlined process brought about by the CTR will strengthen Europe’s position as an attractive location for global clinical research.