(2002; 166 pages)
Cross-border movement of clinical trial subjects and regulatory communication
Dr Rolf Spang, Switzerland
Switzerland is located in the heart of Europe and is divided into 26 cantons which each license physicians and establish ethical committees. Before the recent establishment of a federal authority it was the responsibility of the InterCantonal Office for the Control of Medicines to oversee clinical trials and good clinical practices (GCP).
Switzerland keeps a register of all clinical trials and it is the responsibility of the Swiss Agency for Therapeutic Products to consider applications. Sponsors have to submit documents, such as approval by the ethics committee, the study protocol, the investigators’ brochure and the contract between the sponsors and the contract institute.
Since Switzerland has common borders with several EU countries, there are frequent cross-border movements linked to recruitment of subjects for clinical trials. However GCP regulations have not been developed with this particular situation in mind. When the Swiss authority learned of the clinical trial described, certain issues were identified:
• Direct communication and exchange of information between regulatory authorities is needed when overseas recruitment is discovered.
• Consent documents should be written in the local language understandable to the individual subject.
• The trial subjects should be followed up once the trial is finished, in order to safeguard their health.