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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.

2,867 enrolled on this course

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

Introduction to Randomised Controlled Trials

2,867 enrolled on this course

  • 3 weeks

  • 4 hours per week

  • Digital certificate when eligible

  • Introductory level

Find out more about how to join this course

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.


  • Week 1

    The rationale, design and first steps of a randomised controlled trial

    • Welcome to Week 1

      Welcome to this course on randomised controlled trials. This activity gives you the chance to meet the lead educators on the course as well as giving you an overview of this week and weeks to come.

    • What are Randomised Controlled Trials?

      What are randomised controlled trials?, what impact do they have and why are they so important?

    • Funding & Governance

      How can the data from a clinical trial sample be used to understand a whole population?

    • Week 1 Wrap-up

      Reflection is an important aspect of learning, this activity gives you the opportunity to reflect on the week's material. As well as a chance to test the knowledge you have gained via a short quiz.

  • Week 2

    The importance of statistics and the planning and set-up of a trial

    • Welcome to Week 2

      Welcome to week 2 of the course where we will continue our journey through the life cycle of a randomised controlled trial.

    • Statistics in trials

      Why do we need statistics in trials? How do we ensure our results are precise? How many participants do we need in our trail? These are just some of the questions that we aim to answer throughout this activity.

    • Preparation and set-up for a trial & International Trials

      There are many considerations in the planning to conduct a randomised controlled trial. This section examines some of these considerations and the people involved.

    • Week 2 wrap-up

      Reflection is an important aspect of learning, this activity gives you the opportunity to reflect on the week's material. As well as a chance to test the knowledge you have gained via a short quiz.

  • Week 3

    Delivery of a trial, the analysis and dissemination of trial findings

    • Welcome to Week 3

      This activity, gives you a brief introduction of what is to come in week 3.

    • Participant Recruitment & Data Management

      Why do trials often fail to recruit sufficient participants and how can we overcome this problem? What does informed consent mean and why is it such a critical part of recruiting participants into a trial?

    • Safety and Oversight in Trials

      There may be a number of barriers that hinder the successful completion of a trial, so it is important that there is adequate oversight of trial progress, data collection and of the safety, well-being and interests of trial partic

    • What happens at the end of a trial?

      At the end of a trial, participating sites need to be closed and approval bodies notified. We then focus on the analysis of our trial data, reporting the findings and ultimately informing guidelines for clinical practice.

    • Week 3 Wrap-up

      Reflection is an important aspect of learning, this activity gives you the opportunity to reflect on the week’s material. As well as a chance to test the knowledge you have gained via a short quiz.

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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Ways to learn

Choose the best way to learn for you!

Subscribe & save

$349.99 for one year

Automatically renews

Develop skills to further your career

  • Access to this course
  • Access to 1,000+ courses
  • Learn at your own pace
  • Discuss your learning in comments
  • Digital certificate when you're eligible

Cancel for free anytime

Buy this course

$109/one-off payment

Fulfill your current learning need

  • Access to this course
  • Learn at your own pace
  • Discuss your learning in comments
  • Printed and digital certificate when you’re eligible

Limited access


Sample the course materials

  • Access expires 14 May 2024

Find out more about certificates, Unlimited or buying a course (Upgrades)

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