Lessons From The Front Lines: Navigating The Operational Challenges Of Next-Generation ADC Trials

By Jozsef Palatka, Senior Vice President, Global Head of Oncology

Next-generation antibody-drug conjugates (ADCs) represent one of oncology's most promising frontiers, but their narrow safety margins and complex biology make trial execution uniquely demanding. Drawing on experience across more than 30 global ADC programs involving thousands of patients, this piece examines the operational friction points that most often slow these trials down—from overly burdensome blood-sampling schedules and misaligned imaging visits to rigid biomarker screening requirements that inadvertently exclude eligible patients. It shows how proactive protocol design, flexible screening strategies, and closer collaboration between sponsors and clinical execution teams can meaningfully ease the burden on patients and sites while preserving scientific rigor.

The piece also explores how shifting from periodic, retrospective data reviews to continuous, real-time safety monitoring helps clinical teams catch emerging toxicities earlier and keep patients safely on therapy longer. Together, these approaches offer a practical roadmap for reducing delays, improving enrollment in biomarker-selected populations, and protecting patient wellbeing throughout some of oncology's most operationally complex trials. For teams designing or running next-generation ADC studies, this guide helps build protocols that hold up when they meet real patients and real sites—turning operational complexity into momentum rather than a source of delay.