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A Clinical/Regulatory Perspective On Experience So Far With Biomarkers In EU Approvals Outlook And Challenges

 Rosa Giuliani MD
  3rd-Nov-2017
Description: Stratified and adaptive designs support the value of BM at predicting the outcome (response) but require large sample size. Interim analysis: no improvement of PFS in the full and in the PI3K pathway activated population. Trial stopped for futility at the end of phase II.
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Domain: Medical
Category: Biotech/Pharma
Maxims of Tech: Rules of Engagement for a Fast Changing Environment
Contents:
SESSION 5: OPPORTUNITIES AND CHALLENGES WHEN IMPLEMENTING
PHC CONCEPTS INTO CLINICAL TRIAL DESIGNS

A CLINICAL / REGULATORY PERSPECTIVE ON EXPERIENCE
SO FAR WITH BIOMARKERS IN EU APPROVALS
OUTLOOK AND CHALLENGES
Rosa Giuliani, MD
Breast Unit, S. Camillo-Forlanini Hospital, Rome, IT
Scientific Advisory Group-Oncology_EMA
the views expressed are the personal views of the presenter and may not be und ... See more

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