Module 15 2022

20/05/2022

Clinical Investigation: Design Questions

How to start? Maybe by asking questions… How does your device work – what is its mechanism of action? ● This will help begin to define in whom it should be used

What condition is the device intended to treat? ● This will give you the population that should be included

In the population, are there people with characteristics or conditions that should be excluded? ● This will narrow your population to one where your device is likely to have its best effect

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

41

Clinical Investigation: What should be assessed?

What is the best research question to ask to prove that your device works in the study population? ● How this is framed is critical –the research question often drives what endpoints you will look for ● Endpoints are defined as kind of measure, which indicates if the study was successful or not. As example: Can be a statistically significant improvement in overall survival How much of the population do you need to sample to have enough statistical power ? ● Statistical power is the power to detect if the effects of a treatment at a given level are due to the treatment or just random variation

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

42

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