1 December 2024 – Swissmedic and swissethics have jointly published a position paper on FIHs/early phase I clinical trials involving investigational medicinal products that are being applied in humans for the first time.

In order to ensure the protection of trial participants and to minimize potential risks, Swissmedic and swissethics highlight several points to be considered in the management and practical conduct of FIH/early phase I trials. Therefore, the position paper sets out specific requirements for the design and conduct of such trials to be followed by the sponsor, investigator and site personnel.

For more information, see here.