sitem Center for Translational Medicine and Biomedical Entrepreneurship

Translational Medicine and Biomedical Entrepreneurship

Module 5 - Clinical Trial Design and Performance

 

Content

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

2020: TBA
2021: TBC

Credits

6 ECTS

Fee

The cost of this standalone module is 6'300.– SFr.

Reference

01.005

 

Module Leader

Strategic lead and manager of CTU Bern, University of Bern

PD Dr. Sven Trelle

Sven Trelle is Director of CTU Bern, the clinical trials unit of the Faculty of Medicine of the University of Bern and Inselspital Bern. Originally a physician by training, Sven started to work in patient-oriented clinical research immediately after he finished his medical studies. In 2008 he was elected Associate Director of CTU Bern and responsible for the day-to-day management of the unit. Since 2018 he is Director of CTU Bern. Sven obtained a second degree in Medical Statistics from the University Leicester, United Kingdom.