COMBINE programme launched a pilot coordinated assessment for clinical trials and performance studies
As part of the COMBINE programme, the European Commission and EU Member States have launched a pilot project to test a new, more efficient way of approving combined studies. These studies involve both clinical trials of medicines and performance studies of medical devices.
This pilot is designed to allow sponsors of combined studies to submit a single application, ensuring more harmonised interactions with the Member States involved. This approach is expected to reduce the administrative burden for sponsors and promote transparency and consistency in the assessment process.
What’s the goal?
To simplify and accelerate the evaluation of combined studies under the Clinical Trials Regulation (CTR) and In-vitro Diagnostic Medical Devices Regulation (IVDR), ensuring faster patient access to innovation — while upholding safety and scientific integrity.
The initiative includes two phases:
- Analysis of the challenges at the interface of MDR/IVDR/CTR (including collecting and analysing the challenges reported by various actors involved, mapping relevant national processes and already ongoing work)
- Possible development of solutions that aim to address some of the challenges
The initiative involves representatives of Member States’ competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency and relevant stakeholders from both the medicinal product and the medical device sectors.
The pilot will accept a limited number of studies where the same sponsor is testing a medicine and a companion diagnostic at the same time. The aim is to see how well this new process works and to learn from the experience.
For more information and to apply for the pilot COMBINE coordinated assessment procedure, please visit the European Commission's website.
COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.