Module 15 Presentations

10/04/2024

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

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Clinical Investigation: Planning

Things to be considered, when a study is planned: What should be assessed?  Hypothesis?  Objective?  Which Endpoints?  Which Study Design?

What needs to be in place?  Devices?  Databases?  Vendors e.g. Core Labs?  Committees e.g. Data Monitoring, Adjudication? What is the “regulatory ecology”?  Competent Authority?

How should this be assessed?  Assessments?

 Timings?  Logistics?  Which countries?  Resources?

 Ethics Committees?  Other Authorities?

The Organisation for Professionals in Regulatory Affairs

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