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Managing Adaptive Oncology Trials Within IRB Frameworks

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"Managing Adaptive Oncology Trials Within IRB Frameworks"

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Adaptive clinical trial designs are growing in popularity because they allow for greater flexibility and ethical responsiveness through real-time modifications based on interim data. Oncology trials that use adaptive designs can enhance patient outcomes and treatment efficacy by allowing dose adjustments, treatment arm modifications and early trial terminations. However, managing these trials within IRB frameworks presents unique challenges.

This whitepaper explores best practices for aligning adaptive oncology trial methodologies with IRB requirements. Discover how to stay compliant with federal regulations, ensure trial participant safety, and maintain the scientific integrity of the study.

We explore:

  • Flexible IRB review processes
  • Risk mitigation strategies
  • Approaches to streamline communication between sponsors, investigators and ethics committees
  • And more

Gain insights for effectively addressing complexities so that you can meet regulatory requirements while also benefiting from flexible oncology trial designs. Download now!


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