PSI Webinar: Master protocols - theory, application and regulatory considerations

When:  Sep 23, 2020 from 2:00 PM to 4:00 PM (GB)

Date: Wednesday 23rd September 2020
Time: 14:00 - 16:00 BST
Speakers: Hans-Joachim Helms, Andrew Thomson and Martin Posch

Who is this event intended for? The webinar is intended for the pharmaceutical statistician who works or plans to work with master protocols, the academic who research relates to master protocols, and generally everybody interested in the topic.
What is the benefit of attending? The audience will gain insight into design and regulatory considerations and the conduct of clinical trials with a master protocol.

Registration

You can now register for this event. Registration will close at 12:00 on 22nd September 2020.
PSI Members: Free to attend
Non Members: £20+VAT
To register your place, please click here.

Overview

A protocol of a clinical trial with a design that allows testing multiple drugs and/or multiple sub-populations in parallel, is called master protocol. Master protocols have been used in the pharmaceutical industry for some time now and examples include the I-SPY 2 trial and the Lung-MAP trial. For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies. The speakers will recapitulate terminology surrounding master protocols, present recent advances in the methodological research on master protocols, discuss concerns regarding type I error control and Bayesian approaches, and outline the operational aspects of running a clinical trial with a master protocol through case studies. The speakers will also be available for a Q&A after the presentations.