CRED Understanding Clinical Development 2024

08/10/2024

Clinical development process

Elements of a CDP

• Target product profile (TPP) or target SmPC

Sequential “phased” process…

• Outline of each proposed study

…following a detailed clinical development plan (CDP)

• Timelines, milestones and costs

• “Go” and “no go” criteria

• Assessment of risks and alternative options

Phase I

Phase II

Phase III

MAA

Phase IV

Exploratory Confirmatory

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Definition of clinical development phases

Phase I

•

PK, tolerability & safety

•

Phase II

•

• Proof of concept, dose response, early safety data

Phase III

•

• Confirmation of efficacy at the chosen dose, expansion of safety database

Phase IV

•

• New indications, life cycle management

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