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Course module: BMB510818
BMB510818
Clinical Trials and Drug Risk Assessment
Course info
Course codeBMB510818
EC1.5
Course goals
At the end of this course, the student
- has insight in the basic design principles of a randomized controlled trial
- has an overview of specialized design options for a randomized controlled trial 
- has insight in the basic principles of data analysis of a randomized controlled trial
- has an overview of more specialized principles of data analysis of a randomized controlled trial
- has insight in the principles of drug risk assessment and how to evaluate potential side effects of medication
- has an overview of current regulatory principles for the conduct of randomized controlled trials
- has an overview of common practical issues in the conduct of a randomized controlled trial and suitable solutions
- is able to design a valid randomized controlled trial for any intervention
- is able to read, understand and appraise epidemiological scientific papers on randomized controlled trials
Content
Education form Startdate Enddate Registration period
Face-2-Face 13-12-2021 17-12-2021 BMS_P2_A
Online* 21-06-2022 8-07-2022 BMS_P4_B
*Online courses are only available for Epidemiology students following a full online programme.

Contact details: Educational Office Epidemiology
E-mail: msc-epidemiology@umcutrecht.nl

Registration:
https://www.msc-epidemiology.nl/single-courses.html

Course coordinator:
Dr. G.C.M.(Caroline) van Baal

Course description:
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.

The course program covers 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. Finally the program covers the principles of drug risk assessment in the context of therapeutic research. Seminal lectures on trials and practical exercises are included in the program.

Literature/study material used:
-
  
Mandatory for students in own Master’s programme:
MIght be for a specialization programme of Epidemiology & Epidemiology Postgraduate
 
Optional for students in other GSLS Master’s programme:
Yes
 
Prerequisite knowledge:
Introduction to Epidemiology
Study Design
Clinical Epidemiology (preferred)
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