- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
In accordance with Article 58 of the IVDR, the conduct of combined studies requires authorisation from the JAZMP following the procedure set out in Article 66 of the IVDR.
An exception to this procedure is permitted for combined studies involving companion diagnostics that use only left-over samples. These studies must be notified to the JAZMP in accordance with the procedure described in the Notification of the performance study section.
For combined studies, the JAZMP conducts two separate authorisation or notification procedures. One procedure is for the part related to the in vitro diagnostic medical device, in accordance with the legislation governing medical devices. The other procedure is for the part related to the clinical trial of a medicinal product, in accordance with legislation governing medicinal products. Therefore, the applicant is required to submit two separate applications to the JAZMP: the application for medical devices in the manner described in the Notification procedure for performance studies section, and the application for the clinical trial of a medicinal product via the Clinical Trial Information System (CTIS).
