Why are adaptive designs not routinely implemented in publicly funded setting?

Munya Photo

Munya Dimairo, a medical statistician within the DTS section, has been awarded a highly regarded three–year NIHR Doctoral Research Fellowship to undertake methodological research into the utility of adaptive designs in publicly funded trials.

The main aim of his fellowship is to explore and describe the different forms of adaptive designs applicable in publicly funded confirmatory clinical trials and to provide guidance on their implementation from both a statistical and practical perspective.

In routine practice when planning a trial, it is common to have less than perfect information to inform its design which could later undermine its validity. Furthermore, the assumptions made, at the design stage, are often overoptimistic. Adaptive designs, in which accumulating trial data may be used to modify key aspects of the trial, may be beneficial. More so, there may be other reasons to justify stopping an ongoing trial early either for efficacy or futility. Nonetheless, such designs have drawbacks: they are more complex, are considered controversial in some quarters and may not be amenable to the constraints of public funding bodies. At present, adaptive designs are rarely applied in publicly funded trials.

The fellowship will investigate and address the issues raised by adaptive designs, specifically in publicly funded trials, and provide guidance on their implementation. It will involve a literature review of adaptive designs; qualitative and quantitative work to explore the views of experts using a web based survey and interviews and use both retrospective and prospective case studies of clinical trials to illustrate their implementation.
Munya is supervised by DTS’s Professor of Medical Statistics, Steven Julious and the Dean of ScHARR, Professor Jon Nicholl.

• NIHR Doctoral Research Fellowship (DRF-2012-05-182): Utility of adaptive designs in publicly funded trials; PI: Dimairo M; Co-applicants and supervisors: Prof Julious SA, Prof Nicholl J and Prof Todd SC. £206,221