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 | 13 - 17 May 2024 |
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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.
Structure
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.
Intended Learning Objectives
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.
Target audience
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
Outline
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.
Teaching staff
This course is taught by staff from the University of Bristol including: Trial Methodologists, Trial Statisticians, Trial Managers, Qualitative Researchers and Health Economists.
Bookings
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.
Course materials
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.
Testimonials
96% of attendees recommend this course*.
*Attendee feedback from 2022-2023.
Here is a sample of feedback from the last run of the course:
"Good to have pre-recorded sessions that could be viewed in your own time. The course was comprehensive".
Course feedback, June 2023
"Really comprehensive course which I feel is a great resource both live and to refer back to when designing a trial".
Course feedback, June 2023
"Interesting and useful sessions. A mixture of live, pre-recorded sessions with trainers of various expertise and skills, interactive/ Q and A works well. Really appreciate the wide range of experts and topics throughout the five days".
Course feedback, June 2023
"The course was very informative and covered a broad range of topics. Each lecture was presented well and was clear. I feel I have a good understanding of RCTs or know where to access information required to conduct a RCT. The tutors were very accommodating and answered all questions and I liked the use of the Padlet".
Course feedback, June 2023
"Lectures were interesting, and having a mix of recorded and pre-recorded was good".
Course feedback, June 2023
"A really well run and informative course. Thank you".
Course feedback, June 2023
Bookings for this course are now closed
Dates don't work? Just need a refresher?
Find out about the self-paced Materials & Recordings version of this course [UoB only].