Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a clinical trial involving a simultaneous performance study of in vitro diagnostic devices.
In combined studies, sponsors must apply for approval for both the clinical trial and the performance study before the clinical trial can commence, which can be particularly challenging. The application process has therefore been optimized with a coordinated assessment of applications, ensuring that sponsors can receive simultaneous decisions on both the clinical trial and the performance study. This new coordinated application process aims to simplify and streamline the approval of the combined studies in Denmark.
We expect to update the guideline regularly. Therefore, we encourage all stakeholders to send comments, input, and questions regarding the guideline.