Clinical trials involving IVD performance studies – coordinated assessment pilot

Clinical trial sponsors are invited to express their interest in Phase 1 of the COMBINE Project 1 pilot. The pilot was launched in June 2025 and aims to make it quicker and easier to get approval for international clinical trials that include IVD performance studies. It does this by having regulators and ethics committees review the study at the same time.

HPRA colleagues have co-led the development of the pilot with other national competent authorities together with support from the EMA and the European Commission.

Phase 1 of the pilot will explore the feasibility of a coordinated assessment procedure. This will involve using CTIS for applications which involve a multinational clinical trial of a new investigational medicine and a performance study of an in vitro diagnostic medical device. To participate in the pilot, the same sponsor must be running the clinical trial and performance study.

Clinical trial sponsors can express their interest in participating in the pilot by submitting the following to EUcombinepilot@ccmo.nl:

• Expression of interest form
• Synopsis of their proposed combined study

The deadline for expressions of interest is 31 August 2025.

Further information is available on the COMBINE programme webpage.