3. Designing and Running Robust Trials

Why randomisation and controls are important

Watch this video to find out why randomisation and controls are important in randomised controlled clinical trials. (5:53)

Explore more about this topic in these videos:

Defining a research question using Population, Intervention, Control, Outcome, Timing (PICOT)

Watch this video to find out how a trial question can be defined using PICOT. (13:21)

Download PICOT presentation slides (pdf).

Exercise 1: What is the PICOT of the LATA trial? (Microsoft Forms)

Exercise 2: Define your own PICOT (Microsoft Forms)

Explore more about the importance of PPI in developing the PICOT:

Octopus PPI paper: Enhancing involvement of people with multiple sclerosis in clinical trial design
Trial Talk podcast episode: Octopus: involvement of people affected by MS (SoundCloud)
PROUD PPI paper: “PROUD to have been involved”: an evaluation of participant and community involvement in the PROUD HIV prevention trial

Types of trial designs and when to use them

Watch this video to find out about different phase III clinical trial designs (including multi-arm multi-stage (MAMS), umbrella, basket, factorial, and cluster randomised trials), and when they might be helpful. (14:29)

Download Trial Designs presentation slides (pdf).

Explore more about the MAMS design:

Video: Multi-arm multi-stage (MAMS) trial design (YouTube)
Podcast episode: Optimising treatments with the new MAMS-ROCI design (SoundCloud)

Concepts of bias, blinding and placebos

Watch this video to explore the concepts of bias, blinding and placebos. (6:22)

Download Bias, blinding and placebos presentation slides (pdf).

What influences sample size

Watch this video to explore the factors that influence sample size in clinical trials. (6:47)

Download Sample Size presentation slides (pdf).

What is ‘generalisability’ and why is it important

Watch this video to explore what "generalisability" of a randomised clinical trial is and the importance of this. (4:53)

Download Generalisability presentation slides (pdf)

Designing trials that encourage diversity and inclusion

Watch this video to explore diversity in clinical trials. (5:47)

Download Diversity in Trials presentation slides (pdf)

Exercise: Barriers to participation (Microsoft Forms)

Explore more about diversity in trials:

Feedback form for the PPI training

Content:

Why randomisation and controls are important
Defining a research question using 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

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Go to next Module: 4. Transparency, Reporting and Interpretation

Introduction to Clinical Trials for PPI Contributors - Module 3