The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) to enhance the environment for clinical trials across the EU. The ACT EU is a collaboration between the European Medicines Agency, the Heads of Medicines Agencies and the European Commission. It seeks to transform how clinical trials are initiated, designed, and run. The launch of the MSP will promote collaboration and fosters open dialogue around the challenges and opportunities represented by advances in clinical trials regulation, methodologies, and technology for the benefit of EU citizens. It follows a 2023 public consultation and a workshop. The MSP is a key part of ACT EU, providing a platform for stakeholders to exchange views on all aspects of clinical research including clinical trial design, conduct, statistical analysis, proposals for regulation optimisation, transparency of data, and patient engagement.