There are differences between complex clinical trials and conventional clinical trials, particularly with regards to clinical trial applications (CTAs) and requests for substantial amendments. The Clinical Trials Facilitation and Coordination Group (CTFG) highlights these differences in the Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials published 12.02.2019. These recommendations should be read in conjunction with current legislation regulating clinical trials.
For the assessment of clinical trial applications of studies with complex designs, Swissmedic relies on the recommendation paper of the CTFG.
Complex Clinical Trials (e.g. Umbrella-, Basket- Platform design)
Swissmedic suggests you reading the publication of the CTFG.
Submission of a Clinical Trial Application (CTA) for a clinical trial with complex design
The submission dossier must contain the following documents:
- meet the technical requirements described under Applications for clinical trials for medicinal products
- satisfy the content requirements set in the BW101_10_004e_MB Guideline Clinical Trial Application Dossier
- a flowchart listing the arms/cohorts present in the specific sub-protocol (in case of sub-studies) or in the master protocol (in case of one trial) and the IMP(s) used in each arm/cohort, indicating the status of each arm/cohort (open, closed, interrupted, or discontinued, where the study is already ongoing in another country) and whether each arm/cohort is planned to be conducted in Switzerland.
Last modification 10.11.2026