Sample size calculation in clinical trials: a simulation-based approach

A.Y. 2019/2020
Lesson for
2
ECTS
10
Overall hours
Lesson period
April
Language
Italian
Sample size calculation is one of the basic steps in the planning of any clinical trial. With complex study designs (eg: adaptive studies) or not-standard statistical analyses (eg: mixed models), closed-form expressions or canned software for sample size calculation may not exist. In these situations, setting up a simulation study can solve the problem, allowing to find the optimal sample size for, virtually, any type of trial. The aim of this course is to provide the basis for the sample size calculation of a clinical study using a simulation-based approach. This course will mostly use SAS for empirical examples and exercises. Relevant R code will also be provided.
Knowledge of base SAS (or R) programming and key procedures for the analysis of continuous, binary and time-to-event data.
Assessment methods
Giudizio di approvazione
Assessment result
superato/non superato