Just over 10 years a new approach, Adaptive Trial Design, was going to revolutionise drug development but has it? Here are my...

The traditional 3+3 design, and its variants such as the rolling-6, have been widely, almost routinely used in phase I oncology trials...

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...

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...

All approved oncology drugs here in advanced cancer indications were identified from here with labels accessed in December 2016. A drug...

If you have informative censoring such as when you analyse a blinded, independent, central review (BICR) of progression what can you do?...

Medians exaggerated In an oncology trial, whenever you’ve looked at a Kaplan Meier curve of a blinded, independent, central review (BICR)...

Whilst there are good reasons to believe this might be true, like all good statisticians I’m sceptical until I see some data. If the...