Sample Size Selection in a Clinical Trial

A clinical trial plays a central role in the development of a drug or medical device, and statistical considerations like sample size calculations, are critical for the design of the study.

Clinical trials have different objectives, according to the stage of development. Different statistical methodology will be used for different types of endpoints. Those considerations and other impact the sample size calculations.

During this course we will learn what are the statistical considerations and principles that should be taken into account when determining the sample size of the study, while keeping in mind the business constraints.

Topics To be Covered

• General considerations in sample size calculations
• Impact of clinical and statistical parameters on the resulting sample size
• Types of endpoints
• Hypothesis testing principles including type I error and power (type II error)
• Examples from publications will be provided.