Data Monitoring Committees and Simple Adaptive/Efficient Trial Designs Course

I attended this course on data monitoring committees and simple adaptive designs/efficient trial designs held at University of Sheffield last month. The day was split into two parts in which the morning concentrated on the data monitoring committee side and the afternoon consisted of talks on simple adaptive/efficient trial designs.

The morning session aimed to look at the role and need for a data monitoring committee (DMC), as well as the structure and organisation of one. This was also followed by a practical session reviewing the data in groups and providing recommendations that a data monitoring committee would provide. This exercise was very useful as it provided an insight on the responsibility an independent statistician holds on a DMC and gave a understanding of what it would be like to be on the DMC as an independent statistician.

The afternoon concentrated on adaptive designs and there were talks on case studies and examples of efficient study designs and a talk on options for confirmatory adaptive designs involving treatment selection. Both talks raised very good points most notably;

• In the UK, 55% of all publicly funded trials do not reach their target sample size and studies with 80% power are less likely to recruit to target

• For publicly funded superiority trials a futility assessment would increase successful recruitment from 45% to 64%