Spring Intro 2023

16/02/2023

Secondary endpoint

Selection of clinical endpoints

• Secondary endpoints should measure a range of other relevant aspects to provide context for the primary endpoint

• Exploratory studies often have a lot of secondary endpoints • The aim is to learn

• Confirmatory studies should have fewer secondary endpoints • The aim is to confirm

• Secondary endpoint “wins” cannot overcome primary endpoint failures in pivotal studies

The Organisation for Professionals in Regulatory Affairs

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Clinical endpoints in pivotal studies

It is very important to ensure regulatory authorities agree with proposed endpoints in pivotal studies

Follow guidelines and/or discuss with regulators at scientific advice

The Organisation for Professionals in Regulatory Affairs

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