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LevelConcepts of Clinical Trials (B-KUL-G0B69A)
Aims
The students will learn the specific position that a clinical trial takes in clinical research and to what extent the conclusions are different than from an epidemiological study. The students will also get insight how clinical trials are run in practice. They will also the specific problems that need to be dealt with (dropouts, missing data, interim analyses, etc.).
Previous knowledge
The student knows the basics of statistical inference, notions of regression models and of survival analysis.
Beginning conditions:
Basic concepts of statistical modelling
Linear models
Generalized linear models
Course material
Text book
Slides, transparencies, courseware
Examples and samples
Is also included in other courses
- Master in de statistiek (Biometrics) 120 ects.
- Master of Statistics (Biometrics) 120 ects.
Activities
4.0 ects. Concepts of Clinical Trials (B-KUL-G0B69a)
Content
In the first part of the course, the practical aspects of setting up and conducting a clinical trail are treated. First, an overview of the type of clinical trials is given according to the type of medical treatment. Then, the key players in the clinical trial business: the pharmaceutical company, the research centers and the regulatory bodies like FDA and EMEA will be described. The practical organization of a clinical trial will be reviewed, like establishing a protocol which involves defining the study population, the study endpoints, establishing the sample size, etc.. Randomization is a key issue in clinical trials, we will therefore review the most important randomization techniques used in clinical trials. The second key issue is blinding, its impact will be illustrated using various practical examples.
In the second part of the course, statistical tests which are especially useful for the analysis of clinical trials will be reviewed, restricted to a two-group comparison: Both a frequentist as well as a Bayesian approach will be treated (the elementary notions of a Bayesian analysis will be briefly reviewed). The impact of the type of hypothesis: superiority, equivalence or non-inferiority on the statistical test will be treated. The statistical aspects of sample size calculation will be treated. The impact of dropouts and missing data on the interpretation of the results will be highlighted. The course has mainly a non-technical character.
Description of learning activities
The students will examine clinical trial protocols, critically read published articles and discuss them in a report. An oral defense then follows.
