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