Clinical Trial

Sponsored clinical trials are performed under company assignment and are a special type of contract research. The company legally acts as the sponsor of the trial.

Investigator-initiated clinical trials are own research projects performed under the responsibility of the principal investigator and the hospital (or the university). Such trials might be supported by a company either by contributions in kind or financial contributions. Legally they are treated in the same manner as a sponsored research project.

Freedom of publication may not be restricted by the client. The university researchers must have the right to even publish negative results. Furthermore, the sponsor has to fulfill all obligations assigned by law. In particular, the sponsor has to take over full liability and must indemnify the hospital or the university from all claims by third parties. If, through observations by the researcher, novel intellectual property is created (not already described in the study protocol), then it belongs to the university.

Sponsored clinical trials: Agreements for sponsored clinical trials at the University Hospitals of Basel (UHB), Bern (Inselspital) and Zurich (USZ) are reviewed and negotiated by the respective legal department. Please contact directly the persons responsible at your institution.
Unitectra will draw up agreements for sponored clinical trials at the universities.

Investigator-initiated clinical trials: For own, investigator-initiated clinical trials where the university or the hospital act as the sponsor, Unitectra will provide support in drafting and reviewing collaboration contracts with companies that support the trial. This includes researchers at the University Hospital Basel, the University Hospital Zurich and the University Hospital (Inselspital) in Bern.