Design & Analysis of Cluster Randomised and Stepped Wedge Trials


This course will provide attendees with a clear understanding of the design and analysis of cluster randomised trials and stepped wedge trials.

Overview - Design & Analysis of Cluster Randomised and Stepped Wedge Trials

Cluster randomised trials and stepped wedge trials are increasingly used to evaluate health and social interventions. These trial designs require specific methods of statistical analysis. This course will provide attendees with a clear understanding of the design and analysis of cluster randomised trials and stepped wedge trials. This includes the rationale for using these designs, specific design issues, the randomisation process, sample size calculations, analytical methods, ethical considerations, and trial reporting and interpretation. We will include case studies from low-, middle- and high-income settings. Participants will gain practical experience of data analysis using the computer package Stata.

Who is this course for?

The course is taught in Stata. We require students to have experience of the use of Stata for standard epidemiological analyses (e.g. linear, Poisson and logistic regression).

Applicants should have a good command of English and a working knowledge of clinical trials and statistics.

Accreditation and Assessment

There will be no formal assessment, but participants will receive a Certificate of Attendance.

Course fee

This fee will cover participation in the course and the course materials. It will not include travel costs or accommodation. The fee includes tea, coffee and lunch each day with an evening drinks reception on the first day.

Comprehensive course notes will be given to participants at the beginning of the course along with the course book (Second edition of “Cluster Randomised Trials” by Richard Hayes and Larry Moulton).


This short course is studies on a full-time basis. Lectures and seminars will start at approximately 9.00 and end at approximately 17:00 every day, with an hour for lunch and tea/coffee breaks during the course of the day.

Course objectives
Course Content - Design & Analysis of Cluster Randomised and Stepped Wedge Trials

Course content

By the end of this course, attendees will be able to critique and apply a range of appropriate design approaches and analytical methods for cluster randomised and stepped wedge trials.

The course will cover:

  • Key concepts of cluster randomised trials, including measures of between-cluster variation and the rationale for cluster randomisation
  • Design of cluster-randomised trials, including stratification and randomisation procedures
  • Calculation of sample size
  • Analysis of cluster randomised trials using both cluster-level summaries and individual-level data (random effects models and generalised estimating equations)
  • Design and analysis of stepped wedge trials
  • Ethical considerations, data monitoring and reporting of CRTs

Teaching Methods

Teaching will be through lectures, discussions and practical sessions. There will be a strong emphasis on practical exercises involving participants in the use of Stata to analyse illustrative datasets from a variety of trials. The emphasis is on developing an understanding of the underlying assumptions and principles behind the design and analysis of cluster randomised and stepped wedge trials, on the practical application of the techniques to analyse such trials, and on the correct interpretation of the results. Methods will be illustrated using trials of interventions against infectious and non-infectious diseases, conducted in low, middle and high-income settings.

How to apply
How to apply

Applying for this course


Please read LSHTM's Admissions policies prior to submitting your application.

Short courses - visas, accommodation, disclaimer


The student is responsible for obtaining any visa or other permissions to attend the course, and is encouraged to start the application process as early as possible as obtaining a visa for the UK can sometimes take a long time. The Short Courses team can provide supporting documentation if requested.

Accommodation and meals

A list of hotels located in the vicinity of LSHTM, along with further resources for short term accommodation, can be found on our accommodation pages. Tea and coffee vouchers will be provided during breaks.

Evening meals are not catered for at LSHTM, however there is a large choice of restaurants, cafés and shops nearby.

Important information

Please note:

  • If you have been offered a place on the course you will not be able to register without bringing formal ID (Passport) and without having obtained the correct visa if required.
  • It is essential that you read the current visa requirements for short course students.
  • LSHTM may cancel courses two weeks before the first day of the course if numbers prove insufficient.  In those circumstances, course fees will be refunded.
  • LSHTM cannot accept responsibility for accommodation, travel and other losses incurred as a result of the course being cancelled.