Wheeler, GM; Mander, A; Yap, C; (2018) Practical implementation of dose-response adaptive trials. In: Wiley Statsref: Statistics Reference Online. Wiley: Hoboken, NJ, USA.

Text Practical implementation of dose-response adaptive trials - Mander et al 2018.pdf - Published Version Access restricted to UCL open access staff Download (104kB)

Abstract

The main role of dose–response phase II trials within a clinical development plan is to identify a potentially efficacious dose that can be explored in phase III trials. Traditionally, designs have investigated a fixed set of doses with equal numbers of participants on each dose. Usually these designs are fixed before any data have been observed and it is rarely possible to select the most efficient choices. The dose range under investigation may include doses that have little or no observable effect or the doses that are too high and potentially have toxicities. A dose–response adaptive trial allows changes to the doses selected during the conduct of the trial in order to make better dose choices. The better dose choices could be to allow the most efficient estimation of the dose–response relationship or to select the most promising dose. This article highlights the various issues with trying to implement dose–response adaptive designs and demonstrate the compromises that need to be made between optimal choices and the reality.

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