PSI – Webinar on Master protocols: theory, application and regulatory considerations

Statisticians in the Pharmaceutical Industry (PSI) will hold a webinar on Master protocols – theory, application and regulatory considerations next September 23rd. The event is addressed to experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies. Martin Posch, professor of Medical Statistics at the Medical University of Vienna, head of the Center for Medical Statistics, Informatics and Intelligent Systems, and member of EU-PEARL will introduce the project.

The webinar will cover terminology surrounding master protocols, recent advances in the methodological research on master protocols and outline the operational aspects of running a clinical trial with a master protocol through case studies. During the session, concerns regarding type I error control and Bayesian approaches will be discussed.