01.12.2024
Position paper by Swissmedic and swissethics on clinical trials with medicinal products examined for the first time in humans
During clinical trials with medicinal products in early development phases (i.e. first in human application, early phase I studies) new investigational medicinal products are examined for the first time in humans. Initial insights are hereby collected on their tolerability and safety. To ensure the protection of the trial participants to the greatest extent possible, special aspects have to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres. Swissmedic and swissethics have summarised these aspects in a position paper.