Introduction to Randomised Controlled Trials (FutureLearn)

On this three-week course from the University of Birmingham, you will be guided through the lifecycle of a trial from conception to publication.
Discover the importance of statistics and planning in a clinical trial
There are many factors to creating and executing a trial. From formulating a clear research question to regulations and funding, a lot needs to be done before starting a medical trial.
You’ll begin this course by looking at the different phases of trials and the steps required to conceptualise, design, and plan a successful trial.
Then, you’ll examine the specialist roles involved in every step of the trial process and learn the importance of these individual inputs in the conduct of a successful trial.
Understand how to manage and interpret trial findings and data
The work isn’t finished once a trial is over; there’s a variety of data points and procedures that need to be managed in order to report on the trial findings.
This course will take you through the management processes for trial data and the end of trial procedures that need to be followed. You’ll also look at safety reporting and how randomised control trials are published.
Learn from the experts at the University of Birmingham
This course has been built by a team of expert research trial staff from the Birmingham Centre for Clinical Trials within Birmingham University. This team will guide you through the entire process for conducting randomised controlled trials and how to report results that can then be used to inform guidelines.

What topics will you cover?

Week 1: The rationale, design and first steps of a randomised controlled trial
Week 2: The importance of statistics and the planning and set-up of a trial
Week 3: The delivery of a trial, and the analysis and dissemination of trial findings

What will you achieve?
By the end of the course, you‘ll be able to...

• Describe the key features of the randomised controlled trial and explain why it provides the best evidence of the effectiveness of healthcare interventions.
• Formulate a clear research question using the PICO (Population, Intervention, Comparator, Outcome) format.
• Describe the regulatory and ethical legal frameworks that govern trials and list the processes - implemented into trials to ensure patient safety and data integrity.
• List and define the essential documents and management plans required to plan and deliver efficient and successful randomised controlled trials.
• Recognise the benefits of involving patients and the public in the design and delivery of trials.

Identify the varied roles and responsibilities of specialist trial staff.

• List the information that a statistician needs to calculate the required sample size for a trial; recognise some of the key issues and considerations when analysing the results of a trial and interpret statistical results.
• Identify the necessary guidelines for the dissemination and publication of trial findings

Who is the course for?
This course is designed for new or existing clinical trial staff. It may also be of interest to anyone looking to learn more about the wider randomised controlled trials process.