We are on a mission: Transform clinical trials in Europe
On International Clinical Trials Day 2023, I would like to remind everyone about the strengthened efforts to create an attractive, favourable?and innovative environment for large clinical trials respecting the highest standards of transparency and safety for?all?participants.?
During COVID-19, we faced the need to quickly run multinational trials in Europe and beyond on new vaccines and treatments to ensure timely and efficient protection of citizens against the new virus. EMA and global regulators, as part of the International Coalition of Medicines Regulatory Authorities (ICMRA), outlined already in 2020 the key characteristics of those trials that are most likely to generate conclusive evidence to enable the assessment of effective and safe treatments: large, well-designed and completed. To further facilitate the generation of robust clinical evidence for future public health emergencies via multinational trials, EMA is closely working with national and international experts in clinical trials and regulators to establish efficient and harmonised mechanisms.
When it comes to what is being done concretely at European Union level, I want to point out the Accelerating Clinical Trials in the EU initiative, known as ACT EU: it is a collaboration between the European Commission , the Heads of Medicines Agencies and EMA that seeks to transform overall how?clinical trials?are initiated, designed and run in Europe.
As part of ACT EU, we published?recommendations?that aim to facilitate the conduct of clinical trials with decentralised?elements, which are in the focus of this year’s International Clinical Trials Day. Decentralisation can refer to aspects such as digital tools and telemedicine, home health visits, remote monitoring and diagnostics, direct shipments of study drugs to patients and electronic informed consent. Decentralisation has a lot of potential as it can, for example, reduce the need for patients to travel to trial sites, make the enrolment available to a wider demographic of people and reduce drop-outs.
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We continue to implement and improve the Clinical Trials Information System, CTIS. The single submission of a clinical trial via CTIS facilitates large scale multinational trials, enhances transparency and provides a secure workspaces for collective work by regulators and ethics bodies in EU Member States.
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the CTIS. I invite those interested to send their comments before 28 June 2023. Your input will help us to find the best way to balance?clinical trial?transparency with confidentiality requirements, but also improve user experience and reduce the risk of data breaches. Following the public consultation, we will work on a revision of the transparency rules that will hopefully apply by early 2024.
We are committed to enhancing the environment for clinical studies in Europe - through bigger, better and faster trials we can improve how we address important health issues, like cancer or rare diseases, bring new medicines to patients quicker, optimise patient experience and more effectively respond to public health emergencies.