Event

UCL - Sample size calculations in randomised clinical trials: Beyond the basics

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Date: 4th March 2025
Location: MRC CTU at UCL, 90 High Holborn, London, WC1V 6LJ
Course Type: Short Course

Overview

This one-day course is aimed at 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. .

This course aims to help participants:

  • Understand the underlying statistical principles of sample size calculations from the hypothesis testing framework.
  • Understand the practical issues in calculating sample sizes.
  • Know and use different sample size formulae for different outcome types: continuous, binary, time-to-event, and ordinal outcomes.
  • Know how to calculate power and project the required number of events in trials with time-to-event outcomes based on realistic trial design scenarios.
  • Know about the nuisance parameters and how to specify them in different designs.
  • Know about sample size calculations for complex designs:
    • Factorial designs.
    • Non-inferiority designs.
    • Cluster randomised trial designs.
    • Group sequential designs.
  • Know about blinded and unblinded sample size re-estimation.
  • Know how to use the programs, written in R and Stata, to calculate the sample size for the above design types.
  • Understand how to use simulation to calculate power / sample size.

Sample size calculation for trial design:

Sample size calculations arise in planning a study. It is one of the most important aspects of any design since it drives study timelines and the cost of undertaking the protocol. It determines the degree of required information to robustly answer the primary research questions in the study. If the sample size is too small, the study is likely to be inconclusive. Furthermore, increasing sample size during the study can be expensive and time-consuming. Therefore, it is imperative to accurately estimate the required sample size and trial timelines from the outset, and particularly for any funding application.
This course builds on a basic course in sample-size calculations such as the one provided by the ICH, 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, including factorial, non-inferiority, group sequential, and clustered randomised clinical trials with wide range of outcome distributions. It uses real advanced trial examples to calculate the sample size using the available user-written software in both R and Stata.

Registration

To find out more and register, please click here.

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