Designing and Conducting Pragmatic Randomised Controlled Trials

Description:

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.

 

Aim:

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.

 

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. Provide an introduction on strategies to increase inclusion of underserved groups in trials; 
6. use strategies to enhance trial recruitment, adherence and retention;
7. understand the distinctive concepts in the analysis of clinical and health economic data in pragmatic randomised trials; and
8. 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;
• 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.
   

Cost:

£1,250

Website and registration:

Register for this course

Region:

South West

Keywords:

Randomized Control Trials (RCT)

Related publications and presentations from our eprints archive:

Randomized Control Trials (RCT)

Back to the training database