Feedback from kick-off meeting of the multi-stakeholder platform
date: 29/06/2023
The meeting was a hybrid event with representatives of interested stakeholder groups attending on-site at the EMA building in Amsterdam.
The two-day meeting included seven panel discussions on the feedback from the MSP public consultation and on priority areas identified in the consultation, namely:
- the creation of an invigorated clinical trials (CTs) environment
- the implementation of the CTR
- the role of ethics committees in CTs
- transparency of CTs
- supporting non-commercial CTs
- reinforcing coordination between scientific advice and CT approval
- key features a multi-stakeholder platform should have
During the meeting stakeholders were presented with the work undertaken by the Methodologies priority action, and were able to provide their views on the most relevant trends in clinical trial methodology for which regulatory guidance is needed.
A summary of the outcome of a closed workshop on CTs in public health emergencies (PHE), held on 9th June, was also provided.
Patients and representatives of healthcare professionals participated in each of the seven panel discussions.
Emerging from the discussions was a high interest in harmonisation, simplification, patient-centricity, purposeful transparency, and developing impactful CTs that are context-appropriate. There was agreement on the need for an EU platform to enable discussion and increase alignment between ethics committees from different Members States in the EU. The participants also agreed on a model for the establishment of the MSP, starting from a strategic advisory group working with ACT EU and facilitating multi-stakeholder workshops on specific topics.
A video recording of the event is available on the dedicated event page.