Transforming First-In-Human Oncology Trials: A Strategic Guide

This guide offers a strategic framework for executing first-in-human (FIH) oncology trials, which represent one of the most intricate and high-stakes stages in drug development. Drawing from extensive experience in early-phase oncology, Ergomed outlines a patient-centric and risk-based approach that addresses key challenges, including regulatory complexities, patient recruitment limitations, academic site delays, and gaps in patient engagement. The guide emphasizes the importance of regulatory readiness through proactive gap analysis and dose escalation planning. Additionally, it promotes trial designs that prioritize patient education and support, ultimately enhancing retention and data integrity. The ultimate goal is to reduce regulatory and operational delays, improve recruitment and retention in rare cancer indications, and build enduring trust with patient communities.