Clinical Trials Unit Bern
Clinical studies are a prerequisite for advancing our understanding and treatment of disease. They provide relevant information on disease pathogenesis, epidemiology, prevention, diagnosis, treatment and rehabilitation if conducted according to established scientific standards.
There are two major aspects of a good study: (1) does the study ask an important question and (2) does it answer it reliably. In several workshops the Swiss National Science Foundation (SNF) had spotted the need to improve the quality of clinical research in Switzerland. Based on this finding, the SNF initiated a program to fund clinical trials units in 2007. The aim of these units should be to coordinate and support patient-oriented clinical research.
Patient-oriented clinical research refers to different study types, including randomized controlled trials, cohort studies, case-control studies, case series and diagnostic accuracy studies. The Faculty of Medicine of the University of Bern applied to this initiative and was selected as one of three faculties in the first call. CTU Bern was formally founded at the end of 2007 and established over the next five years with decreasing funding by the SNF. A prerequisite of the SNF support was sustained funding by the host institution (in our case the University of Bern). Originally, CTU Bern was established as an independent unit of the Direktion Lehre & Forschung of the Inselspital Bern. In August 2012 SNF support for the CTU ended and it was decided that sustainability is best achieved by integration of the unit within the Department for BioMedical Research DBMR (formerly Department of Clinical Research) of the Faculty of Medicine with the aim to bring together all clinical research activities of the faculty. Consequently, CTU Bern was one of nine core facilities of the Department for BioMedical Research DBMR since January 2013.
The Clinical Trials Unit (CTU) Bern is supporting the Swiss TAVI Registry with Electronic Data Capture EDC and Central Data Monitoring, using the EDC system Webspirit (2mt, Ulm Germany).