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Strategic Implications Of Trial Design In Early Phase Oncology Studies

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How can pharma sponsors can successfully navigate the critically important early phase development of their oncology therapies? With 2023’s new FDA Guidance for Dosage Optimization in Oncology Treatment (known as Project Optimus) and the increasingly complex and varied oncology therapies landscape, smart trial design is essential to finding success.


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  • How patient-centricity plays a critical role in early oncology trials.
  • Which factors matter most in formulating successful and safe dosing strategies.
  • How dose optimization has changed in a post-Project Optimus landscape.
  • What to consider when making clinical trial design decisions.
  • What resources are available to sponsors navigating oncology’s new trial terrain.


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