30 September 2025
Embarking on a First-in-Human (FIH) clinical trial is a pivotal moment in drug development, where scientific innovation meets ethical responsibility. For sponsors, this phase demands not only strategic planning but also commitment to participant safety, regulatory compliance, and data integrity.
A guidance document published by Swissmedic and swissethics in September 2025 summarizes key sponsor and investigator site requirements. It emphasizes the inherent uncertainty of administering a novel investigational medicinal product (IMP) to humans for the first time, and the potential for serious adverse events. As such, sponsors must adopt a risk-based approach throughout the trial.
Key sponsor responsibilities and investigator site requirements include:
- Comprehensive risk assessment: Sponsors must evaluate the IMP’s safety profile, trial design, and dosing strategy, documenting all considerations and mitigation strategies.
- Protocol precision: Elements such as dose escalation, stopping criteria, and safety monitoring must be clearly defined in the protocol.
- Ongoing safety vigilance: A robust safety management plan must be in place, including real-time monitoring, rapid communication of new safety data, and medical procedures for emergencies.
- Site selection and oversight: Sponsors are expected to choose trial sites equipped with trained and experienced personnel, the necessary infrastructure, and standardized procedures to closely supervise subjects and manage early-phase risks. Specialized phase 1 units should be prioritized.
Ultimately, this guidance reinforces that sponsor diligence is central to ethical and successful FIH trials. By aligning with international standards (ICH GCP, EMA, FDA), sponsors not only protect participants but also lay the foundation for reliable data and future clinical development.
Marietta Hartl
Senior Consultant
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!
