Clinical Trials and Drug Risk Assessment

Course goals

ALL PARTICIPANTS WILL BE PLACED ON THE WAITING LIST UNTIL TWO WEEKS BEFORE THE START OF THE COURSE

GRADUATE STUDENTS:
Please be aware that you can only select a course option that shows the academic year and is offered Face-to-Face (F2F)

POSTGRADUATE STUDENTS:
Please be aware that you can only select a course option that shows the academic year and is offered Face-to-Face (F2F)  or online (depending on your registration)

(FYI: the other options are options for Continuing Education (onderwijs voor professionals))




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

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

Registration:
Face-to-Face: You can register for this course via Osiris Student. More information about the registration procedure can be found here on the Students' site. NOTE Students of the MSc Epidemiology (Post Graduate) that register in time (i.e. at least two weeks before the start of a course) will always be admitted to the course unless it is completely full. Other students will receive information about their application two weeks before the start of the course.
Online: Online courses are only available for Epidemiology Postgraduate students and can register via Osiris Student. More information about the registration procedure can be found here on the Students' site.

Course coordinator:
Dr. G.C.M. (Caroline) van Baal, UMC Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, the Netherlands

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 in Etiological Research
Clinical Epidemiology (preferred)