Clinical Trials and Drug Risk Assessment

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. This online medical 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.

Dr. G.C.M. (Caroline) van Baal
Associate Professor, UMC Utrecht
  • 3 weeks - 14 hrs / wk
  • Academic Certificate
  • 1.5 EC
  • Online
  • English
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Inschrijving sluit op 09/06/2025 331 dagen tot einde inschrijving
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Course description

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 touches on the principles of drug risk assessment in the context of therapeutic research.

Learning objectives

By the end of the course, you should be 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


This Clinical Trials and Drug Risk Assessment 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.

Academic Certificate

To enrol in this course, you need:

• A BSc or Master’s degree in (Bio)medical or Life Sciences
• Sufficient proficiency in English reading and writing
• Sufficient understanding of epidemiology, statistics and data analysis. Elevate courses offering this knowledge include Introduction to EpidemiologyStudy Design in Etiologic Research and Clinical Epidemiology
• Programming skills and knowledge are preferred

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