Case Study
Supporting Tomorrow’s Breakthroughs with Statistical Partnerships for Master Protocols BACKGROUND Master protocols are innovative clinical trial frameworks designed to evaluate multiple treatments, disease types, or both within a single, overarching study structure. In fields like oncology and rare diseases where the genetic basis of the disease can vary widely among patients, master protocols come into their own, and encompass three types: ■ Basket trials, which test a single drug in different diseases ■ Umbrella trials, which explore multiple treatments for a single disease ■ Platform trials, which are ongoing and can add or remove therapies over time By enabling simultaneous investigations, master protocols significantly accelerate research, and enable the development of treatments to meet individual patient needs.
PROJECT BACKGROUND Our client is a leading institution coordinating a master protocol trial in an indication of significant unmet patient need. The platform trial is evaluating multiple investigational products for the indication in partnership with pharmaceutical organizations, research centers and multiple outsourcing partners. The client sought support for the operational biostatistics and programming aspects of the project and was keen to explore technology capabilities for data ingestion and review to address the need for collaborative and rapid decision-making.