Mastering Master protocols: Proposals and open questions

Date: Tuesday 22 November 2022, 3.00PM
Location: Newcastle University
Newcastle University
TR4, 4th Floor, Herschel building.
Local Group Meeting


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Title: Mastering Master protocols: Proposals and open questions
Speaker: Thomas Jaki (Professor of Statistics at University of Regensburg and MRC Biostatistics Unit)
 

Title: Mastering Master protocols: Proposals and open questions
Speaker: Thomas Jaki (Professor of Statistics at University of Regensburg and MRC Biostatistics Unit)

Abstract:

Master protocols are a new class of clinical trial designs that allow treatment arms to enter and leave the trial and/or (sub)-populations to be added over time. They include platform, Basket and Umbrella trials and have proven to be particularly popular during the COVID-19 pandemic where about 60 trials have been registered as a platform trial. A common feature of these designs is the desire to answer several research questions within a single protocol. One of the questions arising from this feature that has generated a lot of discussion in the literature is the need for (or lack of need to) control error rates as well as the most appropriate type of error control. Another core feature of Master protocols is the desire to maximise the utility of information in the study by using the same information to answer multiple research questions (e.g. shared control group in platform trials or information borrowing in Basket trials).

In this talk I will reflect on the discussion around error rates and introduce different possible testing strategies that could be considered for Master protocols and platform trials in particular. I will then discuss strategies to borrow information across different research questions and discuss implications of such strategies on the sample size requirements of the study. Throughout this presentation I will highlight areas where further research is necessary to enable Master protocols to unleash their full potential.

 
Thomas Jaki, PhD
Professor of Statistics at University of Regensburg and MRC Biostatistics Unit
 
Aamir Khan for RSS North Eastern Local Group