Statistics in clinical trials. [ LSTAT2330 ]
5.0 crédits ECTS
22.5 h + 7.5 h
2q
| Teacher(s) |
Legrand Catherine ;
Robert Annie ;
|
| Language |
French
|
Place
of the course |
Louvain-la-Neuve
|
| 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.
|
| 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.
|
Cycle et année
d'étude |
> Certificat universitaire en statistique
> Master [120] in Biomedical Engineering
> Master [120] in Public Health
> Master [120] in Statistics: Biostatistics
> Master [120] in Biomedicine
> Master [60] in Biomedicine
|
Faculty or entity
in charge |
> LSBA
|
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