Master protocols, in particular basket, umbrella, and platform trials, are becoming increasingly popular in medicine. In contrast to traditional trial designs, where one drug is tested in a specific disease population and in a single clinical trial, master protocols allows for efficient and accelerated drug development by using a single trial design and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies. However, it is important such trials to be well designed, conducted and analysed to ensure patient safety and obtain quality data to support drug approval, especially considering their level of complexity. This meeting seeks to promote a conversation around the design and analytics surrounding master protocols, bringing together some of the world’s experts in the field from the statistical, clinical and pharmaceutical communities.
09:30 – 09:35 – Welcome remarks – (RSS Medical Section representative) - Rute Vieira
09:35 – 10:20 – Christina Yap (Institute of Cancer Research)
The Rise of Complex Innovative Designs: Basket, Umbrella and Platform Trials
10:20 – 11:05 – James Wason (Newcastle University / MRC Biostatistics Unit, Cambridge University)
Error rate control and statistical analysis issues for master protocols
11:05 – 11:10 – Break
11:10 – 11:55 – David Chang (Glasgow University / Chief Investigator Precision-PANC)
Initial experience of the Precision-Panc Master Protocol
11:55 – 12:40 – Alex Carlton (Principle Statistician, GlaxoSmithKline)
Master protocols in the tuberculosis setting
12:40 – 13:00 – Panel Discussion
13:00 – 13:05 – Final Remarks (RSS Highlands local group representative) – Lorna Aucott (Chair)
Christina Yap (Institute of Cancer Research)
David Chang (Glasgow University/Precision-PANC study)
James Wason (MRC Biostatistics Unit, Cambridge and Newcastle University)
Alex Carlton (Principle Statistician – GSK)
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