Data Monitoring Committees (DMCs) play a critical role in safeguarding trial participants and preserving scientific integrity by reviewing unblinded data and making recommendations to sponsors. Yet the discussions that shape these decisions, held in closed session, are often complex and nuanced.

DMC members must interpret evolving data, weigh competing risks and benefits, and decide on the most appropriate path forward, often amid ambiguity, incomplete information, and conflicting signals.

Key Topics

• Interpreting emerging efficacy data, both within and outside formal interim analyses
• Weighing risk-benefit in complex and evolving clinical contexts
• Managing conflicting signals across endpoints, subgroups, or protocols
• Making decisions when efficacy and safety findings diverge
• Considering actions beyond continue vs. stop, including adaptations to study conduct

In this panel discussion, experienced DMC members will share how they approach these challenges in practice. Attendees will gain insight into the judgment, trade-offs, and discussions that shape critical trial decisions, with opportunities for live Q&A.

Panelists

Malcolm J. Moore, MD, Head, Department of Medical Oncology & Haematology – Princess Margaret Cancer Centre

Dr. Marcos de Lima, Director, Blood and Bone Marrow Transplant and Cellular Therapy Program – Ohio State University

Dr. James Lewis, Chief of Gastroenterology – University of Pennsylvania

Simon Day, PhD, Statistical Consultant

David Kerr, DMC Biostatistician Director – Cytel

Emily Woolley, Senior Director of Biostatistics – Cytel