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Statistics in clinical trials. [STAT2530]
[22.5h+7.5h exercises] 5 credits

Version française

Printable version

This course is taught in the 2nd semester

Teacher(s):

Annie Robert

Language:

French

Level:

Second cycle

>> Aims
>> Main themes
>> Content and teaching methods
>> Other information (prerequisite, evaluation (assessment methods), course materials recommended readings, ...)
>> Other credits in programs

Aims

Objectives
The goal of this course is to propose a broad overview of the statistical aspects of phase 1, 2, 3 and 4 clinical trials.

Main themes

The following topics will be discussed:
- International guidelines in clinical trials.
- Phase 1: pharmacokinetics and pharmacodynamics.
- Phase 1: dose determination: the continual reassessment method.
- Phases 2 & 3: hypothesis tests in efficacy, superiority or
equivalence trials.
- Phases 2 & 3: power and sample size computation, randomisation and
blinding. Application to sequential trials.
- Phases 2 & 3: cross-over and factorial designs.
- Phase 4: pharmacovigilance. Rare events and risk factors.
- Reporting in clinical trials.

Content and teaching methods

The following topics will be discussed:
- International guidelines in clinical trials.
- Phase 1: pharmacokinetics and pharmacodynamics.
- Phase 1: dose determination: the continual reassessment method.
- Phases 2 & 3: hypothesis tests in efficacy, superiority or
equivalence trials.
- Phases 2 & 3: power and sample size computation, randomisation and
blinding. Application to sequential trials.
- Phases 2 & 3: cross-over and factorial designs.
- Phase 4: pharmacovigilance. Rare events and risk factors.
- Reporting in clinical trials.

Other information (prerequisite, evaluation (assessment methods), course materials recommended readings, ...)

References :
Redmond, C. K. and Colton T. (2001), Biostatistics ub Clinical Trials, Wiley.
Fleiss J. (1986), The Design and Analysis of Clinical Experiments. Wiley.

For more information:

http://www.stat.ucl.ac.be/cours/stat2530/index.html

http://www.stat.ucl.ac.be/cours/stat2530/index.html

Other credits in programs

SBIC22

Deuxième licence en sciences biomédicales (sciences biomédicales cliniques)

Mandatory

STAT21MS/ST

Première année du master en statistique, orientation générale, à finalité spécialisée (sciences et technologie)

(5 credits)

STAT22MS/ST

Deuxième année du master en statistique, orientation générale, à finalité spécialisée (sciences et technologie)

(5 credits)

STAT3DA/B

diplôme d'études approfondies en statistique (biostatistique et épidémiologie)

(5 credits)

Mandatory

STAT3DA/P

diplôme d'études approfondies en statistique (pratique de la statistique)

(5 credits)



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Person in charge : Jean-Louis Marchand - Information : issec@stat.ucl.ac.be
Last update :13/03/2007