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. The Design programme aims to improve the efficiency and resilience of randomised trials by proposing new trial designs.

  • Efficiency is the ability to identify a treatment effect (or lack of effect) quickly with best use of resources.
  • Resilience is the ability to reach credible answers when design assumptions turn out to be inaccurate.

We specialise in the development of improved designs for clinical trials and related study types, to enable rapid, efficient and better evaluation of therapies. New design methodology usually requires new software, and we provide user-friendly software packages for internal and external use. We also improve some existing trial designs in a similar manner.

Our Main Areas of Work

Trials that address several questions

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Multi-arm multi-stage (MAMS) platform trials

The MAMS design aims to maximise the efficiency of testing treatments by allowing more flexibility in the trial’s design and the ability to make data-driven decisions as the trial progresses.

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Response over continuous intervention (ROCI) design

ROCI is a type of design that compares a range of different treatment durations, doses or frequencies to identify the optimal one.

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Personalised Randomised Controlled Trial (PRACTical) design

The PRACTical design compares multiple available treatments and provides the best treatment option for each patient.

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Factorial trials

Factorial trials randomise the same participants to more than one treatment (or factor). Our work focuses on how to design, analyse, and report factorial trials, as well as how to decide whether a factorial design is most appropriate. 

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Sharing our expertise in MAMS platform trials

We share our experience of setting up, running, analysing and communicating clinical trials that are designed to address multiple questions.

Improving trial designs

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Advanced sample size software

Sample size calculation is essential to ensure sufficient power to evaluate the effect of a treatment. We develop software packages to help calculate the sample size of complex trials.

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Efficient cluster-randomised trials

Cluster randomised trials are designs where groups of individuals are randomised to treatment or control. Our work focuses on how to optimise their design and to show new ways to understand and report these trials.

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Efficient non-inferiority trials

Non-inferiority trials explore if a new treatment is as effective as existing treatments. We focus on improving the design of non-inferiority trials and provide guidance on how to interpret their results.