International Clinical Trials Day 2022

International Clinical Trials Day is an opportunity to celebrate the important role of clinical trials in advancing science and public health.

2022 is a year of change for clinical trials in the EU: on 31 January, the new Clinical Trials Regulation (CTR) came into application and the Clinical Trials Information System (CTIS) was launched.

The CTR creates a more unified EU research space where the same rules and processes apply for the submission, evaluation and supervision of clinical trials, no matter where in the Union they take place. Before, trial sponsors had to submit clinical trial applications separately to the national regulator and ethics committees in each of the Member States where they planned to run a trial. Now, sponsors are able to use one single process to apply for the authorisation of a clinical trial, regardless of where the trial will take place and which national competent authorities or ethics committees they have to deal with.

We are still in a transition phase now, but all sponsors of clinical trials are urged to get ready: from 31 January 2023 applications for all new trials must go through CTIS.

CTIS is the single EU entry point for all interaction between sponsors and regulators on a clinical trial. The system also has a publicly searchable database that will radically increase transparency of clinical trials data to stimulate information sharing and peer learning among researchers.

As the new rules for clinical trials in the EU are in place, we are now turning our attention to other initiatives aimed at strengthening Europe as a centre for innovative clinical research. Together with the European Commission and our partners in the Member States, we have launched the new EU-wide initiative Accelerating Clinical Trials in the EU (ACT EU) to transform the environment for clinical trials in the EU. The focus of ACT EU will be on:

·??????enabling the conduct of clinical trials, in particular multinational trials;

·??????innovative trial methods;

·??????supporting the modernisation of good clinical practice;

·??????engaging all stakeholders, including patients and trial participants, to proactively deliver inclusive patient-oriented clinical trials.

This is the start of a new era for clinical trials, where bigger, better, more impactful clinical trials will generate robust evidence to translate scientific innovation into public health gains for patients. Of course, running clinical trials would not be possible without the help of all the volunteers who agree to be enrolled as participants in clinical trials every day. Their contribution leads to valuable evidence that is used to understand new and innovative treatments, and ensure access to safe and quality medicines. For your involvement, we say a big thank you!