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Clinical trial design and performance

Module leader: PD Dr. Sven Trelle, Universität Bern



Date and Credits

5 ECTS

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

  • Translation of preclinical data into clinics
  • Design of a clinical study
  • Identification of essential factors in trial conduct
  • Understanding of the ethical and regulatory prerequisites for conducting clinical trials
  • Completion of investigator-sponsor certificate

Learning content

  • Review of R&D results
  • Pharmacometrics
  • Study design
  • Trial conduct
  • Ethical, regulatory and financial aspects of clinical trials

Module leader

PD Dr. Sven Trelle, Co-director Clinical Trial Unit,
University of Bern

Lecturers

Various experts from the University of Basel
and University of Bern