Introduction to Statistics in Clinical Research
Apply fundamental statistics to medical research with an enhanced understanding of clinical trial data and analysis.
Duration
3 weeksWeekly study
6 hours100% online
How it works
Introduction to Statistics in Clinical Research
Upskill in statistics to advance clinical trial and medical research
Whatever role you play in clinical research, having a foundation in statistics is crucial for designing robust studies, analysing data, and interpreting results effectively.
On this three-week online course from the University of Birmingham, arm yourself with statistics skills directly applicable to clinical trials. You’ll gain the confidence to use what you’ve learned to enhance your team’s design, analysis, and interpretation processes.
Get an introduction to statistics to advance clinical trial research
Start with an overview of randomised controlled trials, the gold standard in evaluating healthcare interventions.
Next, you’ll learn how statistics aids in collecting and summarising trial data as you equip yourself with essential concepts like normal distribution and measures of association.
Explore data sampling and statistical inference concepts, including confidence interval and hypothesis testing
Deepen your understanding of statistics in clinical trials by exploring sampling variation and its impact on confidence intervals, p-values in hypothesis testing, and the basics of statistical tests and regression models.
You’ll also examine non-parametric methods and calculate sample sizes. This will enhance your ability to design, analyse, and interpret clinical trials with greater precision.
Utilise statistical analysis techniques to report clinical trials with precision
Towards the end of this course, you’ll apply advanced statistical concepts to robust trial reporting. Explore time-to-event data, strategies for handling missing data and non-compliance, and methods for subgroup analyses and Bayesian approaches.
You’ll also learn the importance of transparent reporting through statistical analysis plans (SAPs) and trial reports to enhance reproducibility and impact.
Syllabus
Week 1
Summarising trial data and estimating treatment effects
Introduction to the course
We start by setting the scene, with a brief reminder of the randomised controlled trial, the gold standard study design to evaluate the effectiveness of interventions in healthcare, and the role of statistics within such studies.
Collecting and summarising data
Clinical trials collect a huge amount of data. During this activity, we will learn about the different types of data commonly collected in trials and how we can best summarise these data to make sense of them.
Estimating the effectiveness of an intervention
Next, we consider ways to measure the impact of different interventions on health outcomes, and estimate how effective one intervention is compared to another.
Week 2
Confidence intervals, hypothesis testing and sample size
Confidence intervals
An estimate of treatment effect comes from a single sample drawn from the population. A different sample would lead to a different estimate. So what range of values could the true treatment effect plausibly take?
Hypothesis testing
We now consider hypothesis testing, used to decide whether the data observed in our trial supports a particular hypothesis. For example, are two interventions equally effective, or is one superior to the other?
Transformations and non-parametric data
A lot of the statistical methods we have covered so far assume that data follows a normal distribution. What can we do when this is not the case?
Determining the sample size for a trial
How do we determine how many participants to recruit to a trial and why does sample size matter?
Week 3
Time-to-event data, missing data/non-compliance, advanced topics
Time-to-event data in trials
Interest often lies in the time taken until a specific event for each participant, such as resolution of symptoms, death, or recurrence of disease. Such data requires alternative statistical methods.
Dealing with missing data and non-compliance in trials
Common problems that affect virtually all clinical trials are missing data and non-compliance with planned interventions. What are the implications of such problems and how are they best dealt with?
Statistical analysis plans and publication recommendations
Statistical analyses need to be planned in advance and reported transparently and accurately. Published guidelines exist for analysis plans, protocol and result papers.
Advanced topics
The course ends with an introduction to subgroup analyses and Bayesian statistical methods, and common problems seen in published trial analyses.
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...
- Identify the key statistical concepts and methods used within clinical trials and other studies conducted in healthcare research
- Summarise data of different data types
- Identify appropriate measures of treatment effect
- Interpret the findings of clinical trials published in the medical literature, including estimates of effect, confidence intervals and P-values
- Critique published analyses of clinical trials, identifying common problems
- Report statistical methods and results appropriately and transparently
- Contribute more confidently to a clinical trial team
- Explain the crucial role that statistics play in a clinical trial, in its design, conduct, analysis, and reporting
Who is the course for?
This introductory course is for anyone already working within clinical research who wants to enhance their basic statistical skills, such as aspiring chief investigators, research nurses, trial co-ordinators, trial managers, data managers, quality assurance team members, and trial administrators. No prior knowledge is needed to join.
What software or tools do you need?
Learners need no specific software, hardware or other resources to complete this course.
Who will you learn with?
I am the Training & Education Lead for Clinical Trials within the Cancer Research UK Clinical Trials Unit hosted by Birmingham University. I have 30 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.
Ways to learn | Buy this course | Subscribe & save | Limited access |
|---|---|---|---|
| Choose the best way to learn for you! | $419/one-off payment | $1,888.99 for a whole year Automatically renews | Free |
| Fulfill your current learning need | Develop skills to further your career | Sample the course materials | |
| Access to this course | tick | tick | Access expires 10 Feb 2025 |
| Access to 1,000+ courses | cross | tick | cross |
| Learn at your own pace | tick | tick | cross |
| Discuss your learning in comments | tick | tick | tick |
| Certificate when you're eligible | Printed and digital | Digital only | cross |
Cancel for free anytime |
Ways to learn
Choose the best way to learn for you!
Subscribe & save
$1,888.99 for a whole 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
$419/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
Free
Sample the course materials
- Access expires 10 Feb 2025
Find out more about certificates, Unlimited or buying a course (Upgrades) Sale price available until 3 March 2025 at 23:59 (UTC). T&Cs apply. | |||
Find out more about certificates, Unlimited or buying a course (Upgrades)
Sale price available until 3 March 2025 at 23:59 (UTC). T&Cs apply.
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- Complete 90% of course steps and all of the assessments to earn your certificate
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