# Statistics in clinical trials.

lstat2330  2020-2021  Louvain-la-Neuve

Statistics in clinical trials.
Due to the COVID-19 crisis, the information below is subject to change, in particular that concerning the teaching mode (presential, distance or in a comodal or hybrid format).
5 credits
22.5 h + 7.5 h
Q2
Teacher(s)
Legrand Catherine; Robert Annie;
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.
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.
Teaching methods

Due to the COVID-19 crisis, the information in this section is particularly likely to change.

The course consists of lectures and discussion of documents distributed during the course.
Practical works are also organised. They aim to: - deepen concepts introduced during the course, - analyse real data using tools presented during the course.
Depending on the evolution of the situation, the course will be given either in presential or remotely.
Evaluation methods

Due to the COVID-19 crisis, the information in this section is particularly likely to change.

Closed-book written exam.
Depending on the evolution of the situation, the written exam could be replaced by a closed-book oral exam organised remotely.
Other information
Prerequisites: Bases of probability and descriptive and inferential statistics, basic knowledge of SAS and R.
Online resources
All necessary resources will be made available via Moodle.
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
LSBA

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

Title of the programme
Sigle
Credits
Prerequisites
Aims
Master [120] in Mathematics

Mineure en statistique et science des données

Master [120] in Biomedicine

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

Minor in Statistics, Actuarial Sciences and Data Sciences

Master [120] in Mathematical Engineering

Master [60] in Biomedicine

Master [120] in Agricultural Bioengineering

Master [120] in Chemistry and Bioindustries

Approfondissement en statistique et sciences des données

Master [120] in Statistic: General

Master [120] in Statistic: Biostatistics

Master [120] in Biomedical Engineering