Statistics in clinical trials.

LSTAT2330  2019-2020  Louvain-la-Neuve

Statistics in clinical trials.
5.0 credits
22.5 h + 7.5 h
2q

Language
Français
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

  • 1

    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.
Bibliography
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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


Programmes / formations proposant cette unité d'enseignement (UE)

Program title
Sigle
Credits
Prerequisites
Aims
Minor in Statistics, Actuarial Sciences and Data Sciences
5
-

5
-

Master [120] in Statistic: General
5
-

Master [120] in Statistic: Biostatistics
5
-

Master [120] in Biomedical Engineering
5
-

Master [120] in Mathematical Engineering
5
-

5
-

Master [60] in Biomedicine
3
-

Master [120] in Biomedicine
3
-

Master [120] in Mathematics
5
-

5
-