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"How Adaptive Oncology Trials Are Accelerating The Path To Approval"

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Oncology clinical trials have been evolving. Years of increasing complexity has resulted in studies that are larger and longer than in other therapeutic areas. The new characteristics of cancer studies require new trial designs that boost efficiency, enhance flexibility and accelerate the path to approval. Adaptive trials are meeting that need by allowing for real-time modifications based on accumulating data.

This white paper sets out the need for adaptive designs in an era of complex, global clinical trials and shows how companies can implement the approaches to accelerate R&D, covering topics such as:

• The forces driving the need for new approaches to cancer trials
• How to use Bayesian methodologies and seamless phase transitions
• Strategies for implementing biomarker-driven adaptations
• Regulatory and ethical considerations and operational challenges
• The future of adaptive cancer trials

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