Towards better, faster clinical trials in Europe! 🔴 💻 Join the LinkedIn live discussion on #ACTEU, the Accelerating Clinical Trials in the EU initiative, with 🎙 Peter Arlett, Head of Data Analytics and Methods Task Force, 🎙 Marianne Lunzer, chair of the of the Heads of Medicines Agencies (HMA) Clinical Trials Coordination Group (CTCG) and member of the Austrian Agency for Health and Food Safety. Hear more about ACT EU's priority actions and how the initiative aims to strengthen clinical research in Europe. When? 🗓️ Tuesday 16 July at 12:00 CEST We invite you to post the questions for our two speakers via the comment section, either in advance or during the LinkedIn event. #ACTEU #HealthUnion #clinicaltrials
How do we ensure faster and better clinical trials in the EU?
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Are there any plans to accelerate the review for phase I studies, as seen in other ex-EU regions? Is there any procedure planned for shortening the timelines for early phase trials?
Does the EMA think it’s also important that the EU remains globally competitive in terms of share of Clinical Trials? Recent data show that the EU‘s global share of CTs has dropped dramatically (-50%) since 2019.
Could you please let us know what are the plans for facilitating the submission and review of complex clinical trials via CTIS? Currently there are many technical limitations for submitting such a trial under a single EU number (limitations on parallel SM submissions, limitations for sub-study notifications, etc.)
Thanks to the organizers for a great session
Dariusz Żebrowski This is a very valid and important question and to improve the current situation we will need support from policy makers. FYI: there is already an initiative ongoing on this topic https://efgcp.eu/project?initiative=EU-X-CT
What are your plans for the near future for digitising the clinical trials?
Performance of clinical trials in the pediatric field are essential to improve medical care and the future perspectives of children with all kinds of diseases. This is so challenging for many reasons that this is rarely done . What action is undertaken to address this challenge?
Thank you for hosting this event on such an important topic! I have a couple questions: 1) What are the main challenges that the EU needs to address to accelerate clinical trials? 2) Clinicians have very little time to engage in clinical research. How does the ACT EU plan on better integrating clinical research within the European health system?
Is CTIS ready to manage all EU trials especially large trials, with more than 12 MSCs?
CHAIRMAN OF THE BOARD
1moI'm sorry that my question is a bit different and is ahead of the topics discussed, but could you please discuss the issue of equal participation of patients from different EU countries in clinical trials? In other words, what should be done to make participation in clinical trials taking place in various EU countries available to all EU citizens, regardless of their country of residence. Now this is very limited due to the different requirements of individual EU countries, in particular the requirement to have health insurance in the EU country where the research is taking place.