CRED Understanding Clinical Development 2024

14/10/2024

Reasons for Failure in Phase III (examples)

Inadequate dose finding in Phase II

Dose

Different patients populations

Incorrect study design

Outcomes don’t confirm surrogate/biomarkers

New Adverse events in larger population

Safety

Missing data, attrition

Data collection

Bias in data collection, handling or interpretation

Wrong statistics

Wrong Standard of Care / comparator GCP issues

Other

The Organisation for Professionals in Regulatory Affairs

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De-risking of Phase III

Modelling and simulation

population pharmacokinetic modeling (popPK) and exposure-response for better dose selection

Adaptive designs

Master protocols

Biomarkers / enrichment strategies

Real World Data

Early engagement with regulators

The Organisation for Professionals in Regulatory Affairs

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