Adaptive Strategies That Accelerate Milestones
and De-Risk Regulatory Approval

Phase 1 oncology trials are undergoing a fundamental transformation. While traditional 3+3 designs were once the industry standard, they are no longer sufficient to meet regulatory demands for dose optimization or the scientific complexity of next-gen therapies. Sponsors must now generate richer dose-finding data, explore broader ranges of doses earlier, and justify recommended Phase 2 doses with far greater rigor.  

What this eBook Covers

• The shift beyond traditional 3+3 designs and how Project Optimus is redefining dose-finding expectations for oncology trials
• Modern model-assisted designs (BOIN, mTPI-2, Bi3+3) and when each offers the greatest strategic advantage
• A clear overview of model-based designs (CRM, BLRM) and how Bayesian methods improve dose-toxicity estimation and patient allocation
• Decision frameworks for selecting the right Phase 1 design based on therapeutic modality, toxicity profile, regulatory needs, and operational readiness
  

What You'll Gain from Reading

Regulators, sponsors, and investigators all recognize that dose selection has become one of the most critical determinants of oncology program success. This eBook helps you:

• Avoid underpowered dose-finding strategies that slow development
• Reduce patient exposure to subtherapeutic or unnecessarily toxic doses
• Improve alignment with Project Optimus and global regulatory expectations
• Strengthen the evidence base that underpins later-phase strategy and labeling
• Accelerate development timelines through smarter statistical design and operational readiness

Download your copy to design smarter, faster, better informed Phase 1 trials.