Design and analysis of clinical trials

This course is designed to give an introduction to the main statistical ideas and techniques that are used in the design and analysis of clinical trials.

Course Outline

Day 1 – Clinical Trial Design

• Introduction – an example of a typical Clinical Trial
• Populations and Samples – introducing the idea of patient populations and patient samples

Practical Exercise

• Measuring Treatment Effects – discussion of the endpoints typically used to measure treatment effects
• Sample Size and Power – introducing the concepts and techniques of sample size and power calculation

• Common Types of Clinical Trial Design – introducing some common types of clinical trial design

2015

Day 2 – Clinical Trial Analysis and Reporting

• Statistical Significance Testing – introducing the concept of statistical significance tests and discussion of commonly encountered types of test

• Estimation and Confidence Intervals – measuring the magnitude of a treatment effect and the concept of confidence interval calculation

• Documenting and Reporting Clinical Trials – discussion of the essential statistical requirements when documenting and reporting clinical trials.

The course lasts two days, running from 10.00-16.00 on each day. The first day introduces the main statistical ideas relevant to clinical trial design, and the second day is devoted to statistical analysis and reporting of clinical trials.

The course would be suitable for anyone who is working on clinical trials, and for those who would like to gain a better understanding of some of the statistical ideas that are nowadays widely used in this area.

Only a very basic knowledge of clinical trials and statistics is assumed. The course consists of a mixture of presentations and practical (computer-based) exercises.