Swissmedic Position Paper on Clinical Trials

The Swissmedic and the Swissethics jointly published a position paper on clinical trials with medicinal products examined for the first time in humans (FIH). With this position paper, Swissmedic and swissethics aim at highlighting several important points to consider in the management and practical conduct of FIH/early phase I trials.

Background

During clinical trials with medicinal products in early development phases (i.e. first in human application, early phase I studies) investigational medicinal products (IMPs) are examined for the first time in humans. Initial insights are hereby collected on their tolerability and safety. The following special aspects have to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres:

• The sponsor has to identify the risks in a clinical trial and to mitigate these risks in the design and conduct of the trial accordingly. The risk assessment should consider the safety profile of the IMP, including the adequate quality of the IMP, the trial set-up, the population studied, the specific pharmacological dose regime and maybe further additional factors. This risk assessment should be documented. According to ICH GCP E6 (R2) the IMP is manufactured in accordance with any applicable GMP. In addition, the sponsor should determine the acceptable storage temperatures, storage conditions and storage times.
  
  
• FIH/early phase I clinical trials should be conducted by trained investigators and site staff which are experienced in conducting early phase trials. They should also understand the specific characteristics of the IMP and of its target mode of action. The trial should take place under controlled conditions and in appropriate facilities preferable in specialized phase 1 units. In addition, emergency procedures and systems that encompass high standards for avoiding harm to trial subjects need to be implemented.

More information is available in the Swissmedic / Swissethics document on General aspects to consider for FIH/early phase I clinical trials with medicinal products published on the Swissmedic website.