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Introduction to Randomised Controlled Trials
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Introduction to Randomised Controlled Trials

02/07/2018 to 06/07/2018
When: 2 - 6 July 2018
Where: Canynge Hall
Bristol Medical School
39 Whatley Road
Bristol BS8 2PS
United Kingdom

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Course aims 

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 RCTs 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.

Course objectives

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

This course is suitable for researchers, trial co-ordinators, clinicians, public health researchers/specialists looking for an introduction to randomised controlled trials (RCTs). This course would be particularly suitable for attendees who may be involved in the design, conduct, analysis or reporting of RCTs in the academic, public health or NHS sector and who have a some or limited experience of RCTs.  

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 and public health trials;
  • intention to treat analysis;
  • alternative trial designs;
  • adjustment for covariates;
  • subgroup analysis;
  • trial reporting;
  • qualitative methods in clinical trials;
  • feasibility studies;
  • health economics in the context of clinical trials;
  • research governance and oversight;
  • trial initiation and management;
  • PPI.



Further Details of the course can be found on the course website: