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Oncology is at the forefront of clinical research innovation and redefining what rigorous clinical evidence looks like. As therapeutic discovery accelerates and scientific advances outpace traditional development timelines, longstanding trial paradigms are being pushed to their limits.

The oncology research landscape, shaped by heterogeneous patient populations, evolving standards of care, and the urgency of unmet medical need, increasingly requires new approaches.

Adaptive and innovative trial designs have emerged as essential tools to address these challenges.

Alongside these advances, regulatory agencies are updating their expectations and frameworks to better align with modern trial design:

• FDA’s Project Optimus emphasizes dose optimization in oncology
• FDA’s Project FrontRunner signals a shift toward RCTs in earlier treatment lines
• ICH’s E20 guideline provides a harmonized framework for the planning, conduct, and interpretation of adaptive designs

The convergence of methodological creativity and regulatory reform is setting a new standard: one where trial designs are more adaptive, evidence is more robust, and patient outcomes are prioritized from the earliest phases of development.

Key Topics

• The principles and practicalities of complex adaptive designs and their application in oncology
• The evolving regulatory guidance shaping their use

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