Clinical trials are designed to test how new medical approaches work in humans and how efficient, safe and economic they are. The prerequisites for such studies, the understanding of the pathophysiology of the underlying diseases, the definition of quantifiable endpoints by clinicians as well as data management and statistics are discussed.
Learning objectives
Once participants have successfully completed this module, they are able to translate preclinical data into clinics and design a clinical study. They further know how to identify the essential factors in trial conduct and to complete of investigator-sponsor certificate. Also, they gain an understanding of the ethical and regulatory prerequisites for conducting clinical trials.
Learning content
Clinical Trial Design and Performance contains the review of R&D results, pharmacometrics, study design, trial conduct and ethical, regulatory and financial aspects of clinical trials.
Lecturers
Various experts from University of Bern and University of Basel.
Start & Duration
2023: January 2023
The completion of this module takes approximately 10 weeks.
Credits
6 ECTS
Fee
The cost of this standalone module is 6'300.– SFr.
Reference
01.005
