Accelerate Drug Development With Master Protocols

By Beth Chamblin, Senior Director, Project Management, Oncology, IQVIA Biotech, and Kelley Coalier, MS, MBA, Associate Principal, Enterprise Transformation Strategy, IQVIA

Master protocols—such as basket, umbrella, and platform trials—are redefining how clinical research is designed and executed, offering a unified, adaptive framework that accelerates drug development. This paper explores the critical role of partnerships and protocol in operationalizing these complex trial structures. It highlights how early stakeholder engagement, centralized governance, and transparent collaboration across sponsors, CROs, regulatory bodies, and patient advocates are essential for success. Central to this approach is a shared commitment to innovation, operational excellence, and patient-centricity. The paper draws on IQVIA Biotech’s experience to demonstrate how strategic CRO partnerships, agile decision-making, and a flexible, interoperable infrastructure reduce inefficiencies and enable rapid iteration.

Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas. Ultimately, this paper provides a roadmap for navigating the operational and relational demands of master protocols, emphasizing that successful execution hinges not only on the strength of the protocol but also on the depth of collaboration.