No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure

A pharmaceutical sponsor is planning to conduct a Phase 1 interventional drug trial in Switzerland. Although the company has substantial experience managing clinical trials in major markets such as the United States and the European Union, this represents its first study in Switzerland, where local regulatory requirements may differ from those in other jurisdictions. The sponsor’s disclosure team faces uncertainty regarding the specific obligations for clinical trial registration in Switzerland.

Key questions include whether registration is mandatory for a Phase 1 study, what types of trial information must be publicly disclosed, the required timing for these disclosures, and the appropriate registry or platform to use for submission. Ensuring compliance with Swiss requirements is critical not only for regulatory approval but also for transparency, ethical standards, and alignment with international best practices in clinical trial reporting.