Clinical Trials and Drug Risk Assessment

"Learn to explain the basic design principles of a randomized controlled trial."

A clinical trial is an exceedingly important instrument in the assessment of treatment efficacy. With regard to clinical trials, the emphasis will be on methodological principles and on the clinical practice of therapeutic experiments. Furthermore, this course addresses the principles of studying the effects of drug treatments on the risks of unintended effects. The accent is on proper formulation of the research problem with a view to clinical and regulatory relevance of the study results, and on requirements for validity in non-experimental research.

Start date(s): 
Face-to-face: 7 december 2020 Online: 21 june 2021
Time investment: 
Face-to-face: five full working days and one exam. Online: three weeks, 14 hours a week.
University Medical Center Utrecht
Faculty of Medicine
Fee:  This fee is exempt from VAT
€ 870
Extra information: 

The face-to-face course consists of lectures, practical exercises, seminars and one final exam. 

The online course includes a take-home assignment. The exact deadline for this take-home assignment will be announced as soon as possible. The take-home assignment is not compulsory. However, if you want to receive the Course Certificate and the credits, it is obligatory to hand in the take-home assignment. You are allowed to redo this once.

Due to the Covid-19 measures our face-to-face takes places online, fulltime. For the exam we make use of the online proctoring system Proctor Exam. 

The course program provides a thorough medical education into the field of clinical trials, covering the principles of therapeutic research design, including design of study, design of data collection, design of data analysis, including some modelling techniques in the analysis to clinical trials, and the interpretation of its results. The program also covers the principles of drug risk assessment in the context of therapeutic research.

By the end of the course, you are able to:

  • Explain the basic design principles of a randomized controlled trial
  • Describe specialized design options for a randomized controlled trial
  • Apply the basic principles of data analysis of a randomized controlled trial
  • Describe the principles of advanced data analysis of a randomized controlled trial
  • Explain the principles of drug risk assessment and how to evaluate potential side effects of medication
  • State common practical issues in the conduct of a randomized controlled trial and suitable solutions
  • Design a valid randomized controlled trial for any intervention
  • Interpret scientific papers on randomized controlled trials


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