Optimizing Global Early-Phase Oncology Trials

By Keya Watkins and Marcia Milholen

Site selection is a critical determinant of success in early-phase oncology trials, where complex study designs and evolving regulatory frameworks demand precise planning and execution. Identifying the right countries and sites requires a balance of scientific, operational, and cultural considerations. Factors such as disease prevalence, patient demographics, healthcare access, and the competitive trial landscape must be weighed alongside the availability of specialized personnel, equipment, and institutional expertise.

Collaboration with local experts, key opinion leaders (KOLs), and patient advocacy groups enhances feasibility by providing nuanced insights into protocol adoption and patient perspectives. Streamlined feasibility assessments and relationship-based engagement with sites reduce administrative burden and promote trust, while early KOL involvement helps mitigate regulatory delays. Flexibility remains essential, as global regulations such as EU CTR 536 and shifting FDA guidance introduce variability in startup timelines. By integrating strong partnerships, local expertise, and predictive analytics, sponsors and CROs can identify and activate the most suitable sites, accelerating trial delivery and ensuring robust data generation to advance oncology therapies for patients.