Statistics in Randomized Controlled Trials

Course objectives

This course gives an overview of methodological issues and challenges in the design and statistical analysis of randomized controlled trials.  We will discuss practicalities and common issues to keep in mind when planning an RCT. We will focus on the key elements of a well-planned RCT, considering different study designs and presenting the most common challenges in the statistical analysis of the results. The topics will be presented based on real examples and cases experienced by the instructors.

The course is divided into three parts:

1. Introduction and main components of RCTs: structure of RCTs, basic study design, possible biases and generalizability, blinding, randomization
2. Hypothesis tests and sample size: different types of tests, different types of outcomes, what to report, sample size calculation and related issues, interim analysis, different study designs (crossover trials, cluster-randomized trials ...)
3. Further challenges in planning RCTs: compliance issues, missing data, practical issues in analyzing and reporting results

A more detailed program will follow.

Who should attend

 You should attend our course if you are planning or are involved in randomized clinical trials, or are interested in expanding your knowledge of trial design and analysis. The course is suitable for both clinical and non-clinical researchers.  

  The course will be taught in English.