Sample size calculations in randomised clinical trials: beyond the basics

Date: Tuesday 30th April 2024
Time: 09:30-17:00 BST 
Location: In-person at: MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, 90 High Holborn, London, WC1V 6LJ, UK

Course coordinator: DR Babak Choodari-Oskooei
Course lecturers: Dr Babak Choodari-Oskooei, Dr Matteo Quartagno, Professor Andrew Copas, Professor Ian White (UCL)

Target audience

Those working on trials and study designs, which includes trialists, trial statisticians, clinicians and other scientists. Familiarity with the hypothesis testing framework (i.e., type I error rate, power, and various effect sizes) are essential. Familiarity with sample size calculation for simple/basic designs is desirable but not essential.

Course overview

This in-person one-day course builds on a basic course in sample-size calculations and provides an overview of the underlying statistical theory for sample-size calculations within the hypothesis testing framework. It addresses practical issues and statistical considerations when calculating sample sizes for a wide range of advanced trial designs and outcome distributions, including factorial, non-inferiority, group sequential, and clustered randomised clinical trials. It uses real advanced trial examples to calculate the sample size using the available user-written software in Stata. Each lecture will include practical session to consolidate the learning of the concepts.

Specific learning objectives

• Understand the derivation of standard sample size formulae.
• Know how to perform standard sample size calculations for trials with continuous, binary, ordinal categorical and time-to-event outcomes. 
• Know how to project the power and events of trials with a time-to-event outcome into the future.
• Know how to perform sample size calculations for group sequential, factorial, cluster randomised and noninferiority trials, and how to account for uncertainty in the design parameters.
• Know how to plan simulation to determine sample size and understand advantages and disadvantages of doing sample size calculations by simulations.
• Understand the underlying assumptions for sample size calculations and the impact of violation of those assumptions to the sample size calculations and learn what can be done to mitigate associated issues.
• Learn about various sample size re-estimation approaches.

To register

If you would like to register for this event, please click here.