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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
> Master [120] in Biomedical Engineering
> Master [120] in Biomedicine
> Master [60] in Biomedicine
> Master [120] in Public Health
> Master [120] in Statistics: Biostatistics
> Certificat universitaire en statistique
Faculty or entity
in charge
> LSBA


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