EU/UK published white paper on platform trials and complex designs
Different types of master protocol designs, more prominently basket and platform trials, have been implemented in cancer research, started more in exploratory phase and now including confirmatory phase
In order to achieve efficiency gain, frequentist and Bayesian statistical approaches have been developed
Operational considerations in master protocol implementation seems to be one of the biggest challenges, along with knowledge gap and regulatory interaction complexity
Mission
Understand the current regulatory landscape in oncology master protocol designs
Assess different master protocol trial designs in different settings (e.g. exploratory vs. confirmatory) to guide implementation and statistical methods
Educate and outreach to other functions to resolve knowledge gaps, also develop practice guidance of master protocols
Members
Name
Company
Projects
Learning from FDA master protocol guidance documents for oncology drugs and COVID-19 treatments: similarities and differences
White papers on master protocol implementation guide and case example reviews