Was The Hype Justified?
Just over 10 years a new approach, Adaptive Trial Design, was going to revolutionise drug development but has it? Here are my...
Phase I oncology – a statistical disaster zone?
The traditional 3+3 design, and its variants such as the rolling-6, have been widely, almost routinely used in phase I oncology trials...
Size, and Shape Matters
We all know that sizing a study is a critical part of trial design but unless you consider the shape of your curves you may be performing...
A golden age for oncology
I've often considered what would be a realistic effect to power an overall survival (OS) trial on. So I thought I’d go look in a few...
Golden age in oncology - methodology
All approved oncology drugs here in advanced cancer indications were identified from here with labels accessed in December 2016. A drug...
Informative Censoring - what to do
If you have informative censoring such as when you analyse a blinded, independent, central review (BICR) of progression what can you do?...
