Beyond Geography: A Former Regulator's Perspective On Multiregional Oncology Trials

By Harpreet Singh, MD, Chief Medical Officer and Former FDA Director, Division of Oncology

In global drug development, multi-regional clinical trials (MRCTs) have moved beyond being a logistical convenience to becoming a cornerstone of regulatory scrutiny. Today’s landscape requires more than just high-level data; it demands a sophisticated scientific rationale for how and where populations are enrolled. Achieving success in this environment means navigating the delicate balance between global efficacy and the specific expectations of local health authorities, who increasingly look for consistency in treatment effects across diverse geographical cohorts.

Drawing on high-level regulatory expertise, this exploration delves into the shifting tides of how clinical data is evaluated. It examines why programs that appear successful on a global scale can sometimes stumble during the final stages of approval. By understanding the criteria used to assess regional representation, sponsors can move away from "one-size-fits-all" trial designs. Instead, they can adopt a more intentional approach that aligns early-stage planning with the nuances of international oversight. Gaining these insights is essential for any team aiming to reduce the risk of clinical setbacks and ensure that promising therapies reach the patients who need them most across the globe.