A clinical trial in Switzerland may have one or more sponsors (ICH GCP E6 (R3) III.3.6.11). For clinical trials with several sponsors, the following requirements must be met:
- All sponsor obligations in accordance with the Clinical Trials Ordinance (ClinO, [SR 810.305]) and the rules of Good Clinical Practice (Art. 5 ClinO, ICH GCP E6(R3)) must be fully ensured.
- The allocation of roles and the distribution of responsibilities among the sponsors must be clearly, transparently, and verifiably documented and contractually defined (ICH GCP E6(R3) II.10.2 and III.3.6.11).
- The conduct of a clinical trial with several sponsors must be transparently disclosed to Swissmedic and the competent ethics committees.
- The sponsors are jointly and severally liable. Either there must be proof of insurance covering all participating sponsors, or each sponsor must explicitly acknowledge joint and several liability and provide corresponding individual proof of insurance.
- In the written informed consent documentation, the names of all involved sponsors must be explicitly and fully stated.
Further information on conducting clinical trials with several sponsors can be found in the Swissmedic guidance document “Questions and answers on clinical trials with medicinal products” and in BASEC.
Clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices involving several sponsors:
The conduct of clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices involving several sponsors remains permissible. Analogous measures are also required for these clinical trials and must be regulated contractually as well as within the quality management system of each participating sponsor (for clinical investigations with medical devices see ISO 14155:2026 clauses 6.9 and 9.1; for performance studies with in vitro diagnostic medical devices see ISO 20916:2019 clauses 5.1 and 5.11).