Delivery format
In person
Course overview
This course will provide you with a thorough understanding of why clinical trials have become so important in the evaluation of healthcare, social care and public health interventions.
Whilst providing an overview of the different phases of clinical trials, the course will focus on the fundamental features of definitive randomised controlled trials. Key decisions surrounding the design of trials, such as methods of randomisation, blinding and sample size, will be explored.
Additionally the course will also introduce key statistical concepts applicable to the design, analysis and interpretation of trials. By the end of the course you'll be equipped with the knowledge and skills to recognise when a clinical trial is needed and contribute to the design of a subsequent trial.
Course delivery
This course involves a variety of teaching methods including lectures, seminars, tutorials, practical classes/workshops and guided independent study.
By the end of the course you'll be able to:
- Distinguish between observational and interventional study designs and identify the most appropriate design for different research questions.
- Explain the fundamental principles of randomised controlled trials and propose methods to reduce bias in the design of trials.
- Summarize the factors that have driven the development of Good Clinical Practice (GCP) guidelines and regulatory requirements in trials.
- Construct appropriate research questions with consideration of population, intervention, control and outcomes.
- Demonstrate that systematic reviews are essential for contextualising trials and recognise the essential processes involved in undertaking a systematic review.
- Critically appraise medical research literature, including systematic reviews, relevant to a particular area of healthcare, social care and public health research.
- Explain key statistical concepts such as probability and statistical inference and interpret measures of treatment effect, confidence intervals and P-values.
- Discuss the need for sample size calculations and the impact of changing trial assumptions on the required size of a trial.
Assignments
- A 2.5 hour unseen examination (weighting 80%)
- A 1,500 word critical appraisal (weighting 20%)
Course Dates
6th - 15th October 2025
Teaching staff
Mr Lee Middleton
Reader in Clinical Trials
Staff profile page for Mr Lee Middleton, Reader in Clinical Trials, BCTU, in the School of Health Sciences, University of Birmingham.
Mr Samir Mehta
Senior Medical Statistician
Mr Samir Mehta is a Senior Medical Statistician based in Birmingham Clinical Trials Unit (BCTU), University of Birmingham.
Entry requirements
This course is for those who wish to understand why clinical trials are so important and are looking to develop the knowledge and skills to recognise when a clinical trial is needed and to be able to contribute to the design of a subsequent trial.
For further information, please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk
Fees and scholarships
Fees for 2025
£505.60
Application process
Non-credit short course
The microcredential and the non-credit short course follow the same course structure, the difference between them both is with the non-credit short course you do not take the assessment at the end therefore you will not receive credits but will receive a certificate of completion, this certificate cannot be converted to credits.
Please note if you apply for the non-credit short course, you cannot swap to the microcredential version once registered.
Places on the non-credit short course are limited so please enquire before if spaces are available.