The Go/No Go Framework: Criteria for Decision Making in Early Phase Studies

Featuring Ellie Grainger, Statistician II at AstraZeneca

Abstract: 'The Go/No Go Framework: Criteria for decision making in early phase studies'.

In early phase clinical development where multiple drug candidates are being trialled, often in multiple disease indications, it is important that good decision making is adopted for future investment. The Go/ No Go framework has been developed as a way to quantify those decisions and provide a consistent approach for studies to use when it comes to the point of decision making. This presentation will explore an overview of the framework, the parameters underlying it and what the resulting outcomes can mean for the decision.

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