The Cancer Drug Development Forum (CDDF) is pleased to share the key takeaways from our recent ACT-EU webinar series, “Collaborating with stakeholders to define priorities for clinical trials and working collectively to address them.”
The first session was held on 15 December 2025 and featured informative presentations from speakers, Marianne Lunzer (Austrian Medicines Agency) and Laura Pioppo (EMA).
These talks were followed by a Q&A session moderated by Fergus Sweeney (CDDF) and Rosa Giuliani (CDDF).
KEY TAKEAWAYS
1️⃣ACT EU is listening to stakeholders through its Multi-Stakeholder Platform and establishing priority actions based on their input:
- ACT EU workplans and priorities reflect stakeholders’ input each year.
- Active 2-way communication on topics of interest (patient involvement, RFIs, CTR optimization).
- Focus groups on AxMPs, Risk based approaches, sponsor CTIS handbook, and training needs for SMEs and academia.
- Metrics and key performance indicators for CTs in EU/EEA published to track new targets: multinational trials to increase from c.900 to >1400 per year by 2030; first participant recruitment to be within 200 days of CTA for >66% of trials.
- The Clinical Trial Map is available and can be searched in all EU/EEA languages.
2️⃣Advice and support for sponsors:
- Support for non-commercial sponsors (regulatory helpdesk, national support map, fee reduction/waiver for Scientific Advice, etc.).
- Pilots on consolidated advice in clinical trials (SAWP/CTCG and pre-CTA) prolonged and open also for sponsors who have already used the offer.
3️⃣Workshops with stakeholders on key priority topics:
- Held in 2025: GCP modernization, Bayesian statistics, paediatric trials, external controls, etc.
- Planned events for 2026: Contractual agreements, Risk based approach, etc.
4️⃣Important parallel activities from the European Commission and Heads of Medicines Agencies to increase attractiveness of the EU/EEA for innovative research in the remit of individual partners:
- Biotech Act proposal launched by the European Commission on 16 December 2025.
- COMBINE initiative of National Competent Authorities and European Commission, with EMA and ethics committees, to streamline and support CTR and IVDR/MDR implementation for clinical trials.
- Heads of Medicines Agencies FAST-EU (Facilitating and Accelerating Strategic Trials) fast-track approach for the authorisation of multinational clinical trials in the EU/EEA.
To watch the recording, click the link: https://youtu.be/Y_-NZUqM_wk
For speaker presentations, visit the CDDF website: https://cddf.org/events/past-events/cddf-meetings-2025/act-eu-collaborating-with-stakeholders-to-define-priorities-for-clinical-trials-and-working-collectively-to-address-them/