The Role Of FDA Initiatives In Early-Phase Oncology Trials

By David Cameron, MPH, Senior Director and Global Head, Novel Trial Design, IQVIA

Project FrontRunner represents a paradigm shift in oncology drug development, championing earlier-line studies to bring novel treatments to patients sooner. Situated within the FDA’s Oncology Center of Excellence, FrontRunner encourages sponsors to embed regulatory guidance into phase I/II designs, from dose-finding through expansion, to accelerate benefit-risk assessments. Early incorporation of Bayesian methods (BOIN, BLRM) and structured dose-expansion cohorts refines both therapeutic index and target population before transitioning into first- or second-line settings. By leveraging adaptive designs and master protocols, trials can seamlessly adapt to emerging safety and efficacy signals, optimize patient selection, and conserve resources. FrontRunner’s emphasis on real-world evidence, diversity, and collaborative engagement with regulators underpins its patient-centered mission. Although challenges remain, the initiative’s alignment with innovative trial methodologies promises to reshape oncology development.