Specialising in the development of improved designs for clinical trials

Traditional phase III randomised trials often require large numbers of patients, take a long time, and cost many millions of pounds. Therefore the Unit specialises in the development of improved designs for clinical trials and related study types, to enable rapid, efficient and better evaluation of therapies.

 

Multi-arm, multi-stage (MAMS) framework

To speed up the evaluation of new therapies and improve success rates in identifying effective ones, we pioneered the multi-arm multi-stage (MAMS) framework for conducting large, flexible platform trials under a single protocol.

View MAMS workshop tutorials

 

Time-to-event outcomes

We have developed advanced methods of designing trials with time-to-event outcomes, where the sample size, power and analysis timings are estimated while taking into account complex factors such as non-proportional hazards, loss-to-follow-up, and treatment changes.

 

Cluster-randomised and stepped-wedge

The stepped-wedge cluster randomised trial is a comparatively new design that is becoming increasingly popular. We are leading the way in developing methodology for sample size, design and analysis of stepped-wedge and other cluster-randomised trials.

 

Other Projects

We also have expertise in the methodology of non-inferiority trial designs, stratified medicine trial designs, accounting for missing data at the design stage, multiple primary outcomes, and many other design-related questions.