Introduction to Clinical Trials for PPI Contributors

Welcome to “Introduction to Clinical Trials for PPI Contributors”. This course is designed for new Patient and Public Involvement (PPI) contributors, as well as anyone interested in becoming involved in PPI activities in research. 

Co-developed with PPI contributors at our Unit, the course provides an introduction to how clinical trials are designed, conducted and reported, and explores the important role that PPI contributors can play throughout the research process.

The course takes approximately 6h 45min to complete and is divided into five modules. Click on each module title below to access that module. You can work through the modules in sequence or return to individual modules at any time.

 Below, you will find the learning objectives and estimated completion time for each module.

1. Foundations of Evidence-Based Medicine (1h)

• What is evidence-based medicine?
• Different types of evidence (the pyramid of evidence)
• Types of observational studies

2. Clinical Trials: Structure and Purpose (15min)

• The process of a randomised clinical trial
• Groups, committees and governance
• Key ethical considerations

3. Designing Robust Trials (1h)

• Why randomisation and controls are important
• Defining a research question using Population, Intervention, Control, Outcome, Timing (PICOT)
• Types of trial designs and when to use them
• Concepts of bias, blinding and placebos
• What influences sample size
• What is ‘generalisability’ and why is it important
• Designing trials that encourage diversity and inclusion

4.  Transparency, Reporting, and Interpretation (2h)

• Transparency: Types of bias
• Where trial results are reported
• Assessing the quality of a trial
• Interpretation of trial results: 
  • Attrition bias (ITT, PP)
  • Absolute and relative differences (risk); risk ratios
  • Statistical significance and confidence intervals
• Common types of plots used to show trial results
• Example of results from a trial

5. Patient and Public Involvement (PPI) (2h 30min)

• What is (and what is not) PPI?
• Brief History of PPI
• Why is PPI important? Examples of impact of PPI
• Types of PPI
• Barriers to effective PPI
• Measuring impact of PPI

Start the course (go to Module 1)