PS21: From Dose Selection to Adaptation: Recent Innovations in Oncology Trials

Designing and analyzing oncology trials has long been a cornerstone for biostatisticians and regulatory scientists, consistently drawing attention and sparking discussions within the field. Reflecting this focus, the FDA has issued multiple guidance documents in 2024 alone, addressing various aspects of oncology trials such as circulating tumor DNA, toxicity assessment, patient-reported outcomes, and dose optimization. Additionally, the FDA's Project Optimus, initiated earlier, continues to make a significant impact, with its effects becoming increasingly evident over time. The statistical field has responded enthusiastically to the unique challenges posed by oncology clinical trials, with constant development and implementation of innovative solutions. In this session, we will highlight several of these innovations that have made, or are poised to make, a profound impact on the design and analysis of clinical trials. In summary, the presentations in this session will provide statistical insights and practical guidance from both regulatory and industry perspectives on innovatively designing and analyzing oncology trials. The discussions will demonstrate the operational and statistical efficiencies of the innovative oncology trial designs as compared to traditional designs.