Innovative Designs in Early Phase Oncology Studies

Early Phase Oncology StudiesEmbracing Innovative Designs in Early Phase Oncology Studies

Advancements in science and technology combined with unmet patient needs are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators alike seek new ways to efficiently move promising therapies from the clinic to approval, and have started to embrace a  streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I, II and III trials. This paper explores considerations critical during protocol design to help ensure the best way forward, including how a seamless clinical trial strategy requires a different mindset than traditional pathways.

Learning Objectives:

  • Review the genesis of the clinical development process
  • Understand how seamless oncology clinical trial strategy differs from traditional pathways
  • Explore alternate clinical trial routes during early phase design to potentially accelerate approval


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