CRED Understanding Clinical Development 2024

08/10/2024

WHAT IS THE ROLE OF A Ph 2 STUDY?

The Organisation for Professionals in Regulatory Affairs

3

Role of Phase 2

⚫ The key objectives of Phase 2 are:

⚫ To determine the effectiveness of an experimental drug

⚫ Identify, evaluate and define the key parameters for an optimal and successful Phase 3 outcome

⚫ Data from Phase 2 will help develop the target product profile (TPP) in order to define: ⚫ Indication statement

⚫ Target patient population ⚫ Inclusion/exclusion criteria ⚫ Acceptable efficacy and safety margins for a positive benefit/risk ⚫ Any safety signals

Labelling Key Claims

⚫ Go/No-go Decision for further investment (Phase 3)

The Organisation for Professionals in Regulatory Affairs

4

2