CRED Understanding Clinical Development 2024

14/10/2024

Clinical Studies to Support Proof of Efficacy

Beatrix Friedeberg, Senior Director,

Regulatory Strategy, International

Global Regulatory Affairs, VERTEX

CRED Clinical Development

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

Clinical Studies to Support Proof of Efficacy

• Purpose

• Study design

• Patient Population

• Control Group

• Response variables

• Analysis

• Methods to reduce bias

• Innovative/Complex trial designs

• Real Work Data

• Other considerations

The Organisation for Professionals in Regulatory Affairs

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