Conducting Early Phase Oncology Studies - Successfully moving through to proof of concept and beyond

Conducting Early Phase Oncology Studies - Successfully moving through to proof of concept and beyond

Available to view on demand.

This one-hour webinar focuses on strategic considerations for the molecule, including a brief review of the dynamic research landscape of oncology drug development, patient recruitment and product development aspects.

  • What is on the horizon in oncology drug development
  • Clinical development strategy and tactics
  • Clinical design and consideration:
    • Early V Late Phase
    • Regulatory considerations
    • Clinical aspects  – cure or control
    • Patient centricity – practical considerations
    • Trial design – early phase  3+3, Rolling 6 and other designs
    • Protocol development – clear unambiguous protocols, sense checking with KOL’s and subject matter experts. The importance of understanding how to ‘operationalize’ the protocol with thorough feasibility
  • Proof of concept – how do you confirm for MAA?

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