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 | 28 April - 2 May 2025 |
|---|---|
| Fee | £1,100 |
| Format | Online |
| Audience | Open to all applicants |
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:
1. understand why and when randomised trials are optimally conducted;
2. address the key questions in designing a trial, including sample size;
3. examine issues involved in the planning, conducting and completing a successful trial;
4. understand how to assess patient experiences and incorporate patient and public involvement effectively in trials;
5. use strategies to enhance trial recruitment, adherence and retention;
6. understand the distinctive concepts in the analysis of clinical and health economic data in pragmatic randomised trials; and
7. 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;
- 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.
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 & 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) 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 3 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 & Recordings' version of this course: Further information and bookings.
100% of attendees recommend this course*.
*Attendee feedback from 2024.
Here is a sample of feedback from the last run of the course:
"Excellent course. Its run over 5 days with times for discussions. I like the start and finish time and the flexibility of listening to lectures at your own time if needed" - Course feedback, May 2024
"The moderators were all approachable to ask questions and provided a wealth of expertise and information" - Course feedback, May 2024
"Easy access to resources, lots of breaks, good combination of live and recorded" - Course feedback, May 2024
"The interactive sessions and discussions with not only the moderators but also other participants sharing their experience was very interesting and helpful, particularly as an early career researcher" - Course feedback, May 2024
"I really liked the quiz and learning about different RCT methods" - Course feedback, May 2024
"The course had very knowledgeable speakers, a clear time table and the option to do additional "homework" to solidify understanding" - Course feedback, May 2024
"Lots of great insights about all aspects of trials. I regularly attend TMGs but did not fully understand all the roles of the attendees, this course has given me a better understanding of each of the elements that make up an RCT" - Course feedback, May 2024
"I've learnt a lot that I can put in practice for the studies I work on" - Course feedback, May 2024
"Experience shared by others has by far been the most valuable learning for me, particularly around how to manage different aspects of designing and conducting a fair trial keeping in mind inclusivity, PPIs and all other cogs of this wheel. also the clarification of roles and responsibilities of different team members through appropriate delegation is a reassuring learning that I'll surely utilise in the future" - Course feedback, May 2024