A new platform is set to facilitate the exchange of information on the optimisation of the electronic reporting system CTIS.
Following strong criticism ahead of the mandatory launch of the CTIS electronic clinical trial reporting portal by the European Medicines Agency (EMA), the EU SME Office has now launched a public consultation on the development of a multi-stakeholder platform to foster collaboration on improving clinical trials in the EU, as envisaged in Priority Action 3 of Accelerating Clinical Trials in the EU.
In particular, an alliance of German biopharma, physician and CRO associations as well as the ethics committees had complained before Christmas 2022 about technical errors of the portal during the one-year transition phase. If these were not eliminated by the start of the portal on 1 February 2023, the goal of shortening the time to approval of a clinical trial would be missed and Europe would fall further behind the USA, Asia and the UK as a trial location. After the launch of CTIS, the EU pharma federation EFPIA, which was fierce behind the scenes, had thanked the EMA for its efforts in fixing the technical bugs and system errors.
The new platform will now host the previously public dialogue among stakeholders on clinical trials and facilitate the development of the clinical trial environment, according to a statement. It will help communicate advances in clinical trial methods, technology and science, and serve as a neutral space to discuss “challenges” and “develop practical solutions”. There will be several development phases leading up to the final design of the platform, which have been summarised in a concept paper. The aim of the consultation, which runs until 3 March, is to gauge interest in the platform, get feedback on priority discussion topics and gather comments on the proposal. The kick-off meeting of the multi-stakeholder platform will take place in Q2/2023.