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Introduction to Randomised Controlled Trials

Discover the importance of trials in evidence-based medicine and learn about the trial lifecycle from conception to publication.

2,985 enrolled on this course

Illustration of the outcomes and purpose of randomised controlled trials which are: better evidence, better treatment decisions and better health.
  • Duration

    3 weeks
  • Weekly study

    4 hours

Explore how successful clinical trials are designed and delivered

Randomised controlled trials have a huge impact on society by providing evidence of the effectiveness of healthcare, social care, and public health interventions.

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.

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Skip to 0 minutes and 7 seconds Across the globe millions of people are living with disease from acute illness to chronic lifelong conditions. From the moment we are born to the day we die we are reliant on access to health care and to life-improving and life-saving treatments. But how do we know how to best treat an individual or how we might prevent disease? How do we decide what really works and what doesn’t? More than 70 years ago a landmark clinical trial was conducted by British scientists looking for an effective treatment for tuberculosis. It was the first study to randomly allocate patients to different treatment groups, enabling a fairer comparison than previous studies. This was the birth of the randomised controlled trial.

Skip to 0 minutes and 58 seconds Since that defining moment, evidence from such trials has enabled a vast number of ineffective treatments to be replaced with a smaller number of effective ones in numerous different diseases and populations. Randomised controlled trials are now widely accepted as the best study design to tell us what works and what doesn’t. And drive important decisions about which treatments and interventions should be endorsed. . Many researchers and scientists around the world work within trials dedicated to discovering solutions to the major burdens of disease and the promotion of health. They enable us to consider such questions as how can more of us survive cancer? How can we best reduce obesity? How can we provide effective care for an ageing population?

Skip to 1 minute and 51 seconds But these trials must be well-designed, ethically sound, and delivered under a strict regulatory environment. The University of Birmingham hosts the Birmingham Centre for Clinical Trials, one of the leading centres in the UK for designing and implementing high-quality trials across a wide range of diseases and clinical settings. During this course, experts from this prominent Centre will take you through the lifecycle of the Randomised control trial from conception through to publication. It will provide you with an overview of the design, delivery, and interpretation of Randomised controlled trials and the impact of such studies on people’s lives.

Skip to 2 minutes and 33 seconds You will learn about the specialist roles of those involved in every step of the trial process and gain perspective on the importance of these individual inputs and the conduct of a successful trial. Whether you are interested in becoming a part of this exciting workforce or you already work within trials but wish to gain a broader knowledge, this is the course for you.

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

When would you like to start?

Start straight away and join a global classroom of learners. If the course hasn’t started yet you’ll see the future date listed below.

  • Available now

Learning on this course

On every step of the course you can meet other learners, share your ideas and join in with active discussions in the comments.

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.

Who will you learn with?

I work as the Training, Education and Strategy Lead for the Birmingham Clinical Trials Unit (BCTU), and I have over 20 years experience of working in clinical trials both in academia and in industry.

I am the Training & Education Lead for Clinical Trials within the Cancer Research UK Clinical Trials Unit hosted by Birmingham University. I have 25 years experience working within clinical trials.

Who developed the course?

University of Birmingham

The University of Birmingham is a public research university, consistently listed as a leading UK university and ranked among the top 100 in the world.

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  • Complete 90% of course steps and all of the assessments to earn your certificate

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