Introduction to Randomised Controlled Trials

Course dates

19-23 June 2017.

Course duration: 5 days (approximately 29 hours teaching).
Registration will start at 9.00am on the first day, the course will finish by 4.00pm on the final day.

Course tutors

Dr Sara Brookes, Dr Niamh Redmond, Dr Clare ThomasDr Zoe Tolkien (course organisers), Professor Alastair Hay, Dr Athene Lane, Dr Birgit Whitman, Dr Vikki Wylde, Dr Kerry Avery, Dr Suzanne Audrey, Dr Elsa Marques, Dr Chris Metcalfe, Ms Clare Clement, Dr Paul Whybrow, Dr Jeff Round, Professor Tim Peters, Dr Jelena Savović, Dr Jess Harris and Professor Richard Morris.

Course aims and objectives

The aim of the course is to provide an introduction to and understanding of the key issues in the design, analysis and reporting of randomised controlled trials (RCTs). The course focusses on randomised controlled trials in the evaluation of healthcare and public health settings. Observational epidemiological study designs, including cross-sectional, cohort and case-control studies, are not covered in this course.

By the end of the course, students should:

  • understand when and why randomised controlled trials are necessary;
  • understand and be able to address the key decisions that have to be made when designing a trial;
  • understand when and how qualitative methods and health economics can add benefit to the design of trials;
  • be aware of appropriate statistical methods in the analysis of trial data, including adjustment for covariates, subgroup analyses and multiple outcomes;
  • be able to design a hypothetical trial based on their knowledge gained throughout the course.

Who the course is intended for

Anyone looking for an introduction to randomised controlled trials (RCTs) and involved in the design, conduct, analysis or reporting of RCTs in the academic, public health or NHS sector. Students will be expected to have a basic knowledge of statistical methods up to the level of the 'Introduction to Statistics' course, and an understanding of research design up to the level of the 'Introduction to Epidemiology' course.

Course outline

The introductory course covers the following topics:

  • the need for randomised controlled trials; 
  • planning and trial design issues; 
  • pragmatic and explanatory trials; 
  • hypothesis testing; 
  • clinical and statistical significance; 
  • sample size;
  • randomisation; 
  • recruitment to trials; 
  • cluster trials; 
  • intention to treat analysis; 
  • alternative trial designs; 
  • multiple outcomes; 
  • adjustment for covariates; 
  • subgroup analysis; 
  • CONSORT guidelines on trial reporting; 
  • qualitative methods in clinical trials; 
  • feasibility studies;
  • health economics in the context of clinical trials; 
  • ethical issues in trials.


Make a booking

Limited places available.

Course fees


More information on course fees, fee waivers and reduced prices.

Course venue

School of Social and Community Medicine
Canynge Hall
39 Whatley Road
United Kingdom

Map and directions

Lunch and refreshments

Coffee, tea, fruit and biscuits will be available to all students. A light lunch is provided for all paying participants. Please let us know if you have any dietary requirements.


Information about accommodation.


For further information please email