Designing and Conducting Pragmatic Randomised Controlled Trials

An online short course

This course aims to provide an understanding of the essentials of designing, conducting and analysing pragmatic randomised controlled trials (RCTs). The course examines RCTs evaluating health and public health interventions in primary, secondary and community settings with individual and cluster randomised designs. This course will not cover regulatory approvals or research governance.

Course date 28 June - 2 July 2021
Course fee £1,100
Course Organisers Professor Athene Lane, Professor Chris Metcalfe, Dr Jodi Taylor, Dr Amanda Lewis, Julia Carver

Course format

This 5-day course will be online, consisting of a mix of live and pre-recorded and practical sessions. Comittment per day approx 50% of that in person.

Course objectives

  1. to understand why and when randomised trials are optimally conducted; 
  2. to address the key questions in designing a trial, including sample size;
  3. examine issues involved in the planning, conducting and completing a successful trial;
  4. to understand how to assess patient experiences and incorporate patient and public involvement effectively in trials; 
  5. to use strategies to enhance trial recruitment, adherence and retention;
  6. to understand the distinctive concepts in the analysis of clinical and health economic data in pragmatic randomised trials;
  7. to gain insight into the experience of being a Chief Investigator and working with registered Clinical Trials Units.

Who the course is intended for

This course is designed for:

  • Trial Managers and co-ordinators
  • Researchers / Administrators working on trials
  • Chief Investigators / Principal Investigators
  • Other specialists looking to understand RCTs including clinicians, health care and public health care researchers

Course outline

This introductory course covers the following topics:
  • Need for randomised trials
  • Design of trials
  • Randomisation
  • Sample size
  • Feasibility and pilot studies
  • Trial planning, resourcing and working with the NHS
  • Trial initiation
  • Qualitative research in trials
  • Patient and Public Involvement   
  • Optimising trial recruitment
  • Trial conduct and closure
  • Protocol adherence and missing data
  • Cluster and public health trials, including in schools
  • Outcome assessment and Patient Reported Outcome Measures
  • Health economics overview
  • Primary and secondary trial analyses
  • Experience of being a Chief Investigator
  • Clinical Trials Unit support for trialists

Online Course Bookings

Bookings are open for online courses running in 2021.

I really loved the course as a whole and learnt a lot from it. I also enjoyed having an opportunity to talk to and meet others.

Course feedback, June 2019

Coronavirus (COVID-19)

We may need to make responsive changes to our courses at short notice in order to follow the latest Public Health, Government and University guidance on coronavirus (COVID-19).

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