🔔 📢 The Cancer Drug Development Forum (CDDF) held a live webinar on “EU Clinical Trial Regulations.” on 12 November at 17:00 CET. This webinar featured two lectures given by Dr Tarec Christoffer El-Galaly (Aahrus University, DK) and Stéphanie Kromar (EORTC, BE), followed by a panel discussion moderated by Prof. Ruth Plummer (CDDF) and Dr Catarina Edfjäll (CDDF). Here are key takeaways from the webinar:
- Overall, the EU Clinical Trial Regulations (CTR) is leading to potential streamlining of processes. However, as with any change, there have been hiccoughs along the way – but a real positive is the supportive responses from CTIS and EMA in facilitating the adoption of the changed process.
- Country-specific issues will remain, and here the most important focus is on Patient Information Sheet (PIS) in the local language so patients can make well informed decisions about joining clinical trials – (and that AI- generated translations are not fit for purpose).
- Timelines are short. there needs to be prioritization and alignment of RFIs to make protocol revisions feasible.
- CTR holds opportunities risk-adapted approaches to safety reporting.
- A common framework for collaboration between national ethics and national medicines agencies is needed to streamline the process.
🔶To watch the recording of the webinar, click the link: https://youtu.be/OiUFTYHsbdY
🔶For speaker presentations, visit the CDDF website: https://cddf.org/events/past-events/cddf-meetings-2024/cddf-live-webinar-eu-clinical-trial-regulations/