# Statistics in clinical trials.

lstat2330  2019-2020  Louvain-la-Neuve

Statistics in clinical trials.
Note from June 29, 2020
Although we do not yet know how long the social distancing related to the Covid-19 pandemic will last, and regardless of the changes that had to be made in the evaluation of the June 2020 session in relation to what is provided for in this learning unit description, new learnig unit evaluation methods may still be adopted by the teachers; details of these methods have been - or will be - communicated to the students by the teachers, as soon as possible.
5 credits
22.5 h + 7.5 h
Q2
Teacher(s)
Language
French
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
 At the end of this learning unit, the student is able to : 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
Redmond, C. K. and Colton T. (2001), Biostatistics ub Clinical Trials, Wiley.
Fleiss J. (1986), The Design and Analysis of Clinical Experiments. Wiley.
Teaching materials
• transparents sur moodle
Faculty or entity

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

Title of the programme
Sigle
Credits
Prerequisites
Aims
Mineure en statistique et science des données

Approfondissement en statistique et sciences des données

Minor in Statistics, Actuarial Sciences and Data Sciences

Master [120] in Statistic: General

Master [120] in Biomedical Engineering

Master [120] in Statistic: Biostatistics

Certificat d'université : Statistique et sciences des données (15/30 crédits)

Master [60] in Biomedicine

Master [120] in Mathematical Engineering

Master [120] in Mathematics

Master [120] in Biomedicine