Re-formulating Gehan's design as a flexible two-stage single-arm trial.

ABSTRACT:

Background

Gehan's two-stage design was historically the design of choice for phase II oncology trials. One of the reasons it is less frequently used today is that it does not allow for a formal test of treatment efficacy, and therefore does not control conventional type-I and type-II error-rates.

Methods

We describe how recently developed methodology for flexible two-stage single-arm trials can be used to incorporate the hypothesis test commonly associated with phase II trials in to Gehan's design. We additionally detail how this hypothesis test can be optimised in order to maximise its power, and describe how the second stage sample sizes can be chosen to more readily provide the operating characteristics that were originally envisioned by Gehan. Finally, we contrast our m

SUBMITTER: Grayling MJ 

PROVIDER: S-EPMC6350340 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature