Statistics in clinical trials. [ LSTAT2330 ]
5.0 crédits ECTS
22.5 h + 7.5 h
2q
| Teacher(s) |
Legrand Catherine ;
Robert Annie ;
|
| Language |
French
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Place
of the course |
Louvain-la-Neuve
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| 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.
|
| 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.
The contribution of this Teaching Unit to the development and
command of the skills and learning outcomes of the programme(s) can be
accessed at the end of this sheet, in the section entitled
“Programmes/courses offering this Teaching Unit”.
|
| Content |
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 |
References :
Redmond, C. K. and Colton T. (2001), Biostatistics ub Clinical Trials, Wiley.
Fleiss J. (1986), The Design and Analysis of Clinical Experiments. Wiley.
|
Faculty or entity
in charge |
> LSBA
|
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