Designing and Conducting Pragmatic Randomised Controlled Trials
Pragmatic Randomised Controlled Trial (RCTs) are the ‘gold standard’ test for evaluating whether a new intervention is better than an existing one and are routinely used in both real-world healthcare and public health settings. Academics working in the Bristol Trials Centre (BTC) and the University of Bristol (including those who are tutors on this course) have all been at the forefront of designing and implementing high quality pragmatic RCTs for this purpose.
| Dates | 17-21 May 2027 |
|---|---|
| Fee | £1,250 |
| Format | Online |
| Audience | Open to all applicants |
| Organisers | Dr Kirsty Roberts, Professor Athene Lane and Professor Chris Metcalfe |
Course profile
This course aims to provide an understanding of the essentials of designing, conducting and analysing pragmatic randomised controlled trials (RCTs). The course examines RCTs evaluating health and public health interventions in primary, secondary and community settings with individual and cluster randomised designs. Please note this course does not go into lots of detail about regulatory approvals and research governance.
Please click on the sections below for more information.
This introductory online course will be taught over 5 full days and to ensure inclusivity will include live, asynchronous and pre-recorded material. The course also includes voluntary interactive elements such as 'Present your own RCT' session.
By the end of the course participants should be able to:
- understand why and when randomised trials are optimally conducted;
- address the key questions in designing a trial, including sample size;
- examine issues involved in the planning, conducting and completing a successful trial;
- understand how to assess patient experiences and incorporate patient and public involvement effectively in trials;
- provide an introduction on strategies to increase inclusion of underserved groups in trials;
- use strategies to enhance trial recruitment, adherence and retention;
- understand the distinctive concepts in the analysis of clinical and health economic data in pragmatic randomised trials; and
- gain insight into the experience of being a Chief Investigator and working with registered Clinical Trials Units.
This course is designed for:
- Trial Managers and co-ordinators
- Researchers / Administrators working on trials
- Chief Investigators / Principal Investigators
- Other specialists looking to understand RCTs including clinicians, health care and public health care researchers
The course will specifically cover:
- need for randomised trials;
- design of trials;
- randomisation;
- sample size;
- feasibility and pilot studies;
- trial planning, resourcing and working with the NHS;
- inclusion in trials;
- trial initiation;
- qualitative research in trials;
- Patient and Public Involvement;
- optimising trial recruitment;
- trial conduct and closure;
- protocol adherence and missing data;
- cluster and public health trials, including in schools;
- outcome assessment and Patient Reported Outcome Measures;
- health economics overview;
- primary and secondary trial analyses;
- experience of being a Chief Investigator;
- Clinical Trials Unit support for trialists; and
- CRF and database design.
This course is taught by staff from the University of Bristol including: Trial Methodologists, Trial Statisticians, Trial Managers, Qualitative Researchers and Health Economists and local NHS partners.
Before booking this course, please make sure you read the information provided above about the target audience.
Bookings are taken via our online booking system, for which you must register an account. To check if you are eligible for free or discounted courses please see our fees and voucher packs page. All bookings are subject to our terms and conditions, which can be read in full here.
For help and support with booking a course refer to our booking information page, FAQs or feel free to contact us directly. For available payment options please see: How to pay your short course fees.
Participants are granted access to our virtual learning platform (Blackboard Ultra) 1 to 2 weeks in advance of the course. This allows time for any pre-course work to be completed and to familiarise with the platform.
To gain the most from the course, we recommend that you attend in full and participate in all interactive components. We endeavour to record all live lecture sessions and upload these to the online learning environment within 24 hours. This allows course participants to review these sessions at leisure and revisit them multiple times. Please note that we do not record breakout sessions.
All course participants retain access to the online learning materials and recordings for 5 months after the course.
University of Bristol staff and postgraduate students who do not wish to attend the full course may instead register for access to the 'Materials and Recordings' version of this course: Further information and bookings.
100% of attendees recommend this course*.
*Attendee feedback from 2026.
Here is a sample of feedback from the last run of the course:
"There was a wonderful amount of content, which was hugely illuminating for current pilot study work and for planning a future RCT. The course was very comprehensive." - Course feedback, July 2026
"It was a very good mix of live, pre-recorded, small group and individual work. It felt very well planned. The facilitators felt expert and also like they all knew each other and got on well. I really liked the timing of the course too - sessions mostly started at 9.30 and finished before 3 allowing me to do school pickup around the course which I really really appreciated - it made it so much more accessible for me. Lecturers were really responsive to answering questions both in session and on padlet." - Course feedback, July 2026
"Stepping through the practicalities of running a trial. Having access to so many different people with different expertise on different aspects of RCTs. I found it useful to do the mini presentation too." - Course feedback, July 2026