Balancing Innovation, Ethics, and Operational Excellence in Adaptive Oncology Trials

Clinical trials are evolving to incorporate adaptive designs, offering flexibility to refine protocols based on emerging data. Oncology studies that leverage AI, machine learning and other technologies are at the forefront of this innovation. However, such advancement introduces operational and ethical complexities that must be addressed to safeguard patients and ensure trial integrity.

Leading experts in cancer research will come together to discuss how to navigate the complexities of adaptive trials designs and how ethics reviews uphold patient safety, ensure informed consent, and provide robust oversight for evolving trial designs.

Key learning objectives:

• Define adaptive trial design and understand its benefits, key components, and role in optimizing clinical trials for efficiency and flexibility
• Identify and address operational and ethical challenges in adaptive trials, including managing frequent protocol amendments and effectively integrating new technologies into trial workflows
• Explore strategies to align site selection, recruitment, and enrollment with trial design goals
• Discover best practices for transparent informed consent, implementing real-time ethical oversight, and fostering collaboration among stakeholders to uphold ethical standards throughout the trial lifecycle

• Presenters

Anthony W. Tolcher

MD, FRCP, FACP

CEO and Co-founder, Next Oncology

Dannelle Palmer

Chief Operating Officer, Kapadi

Alex Kaizer

Associate Professor of Biostatistics and Informatics, Department of Biostatistics & Informatics (B&I) and the Center for Innovative Design and Analysis (CIDA)

Luke Gelinas

PhD

Senior IRB Chair Director, Advarra