The DURATIONS randomised trial design: Estimation targets, analysis methods and operating characteristics.

ABSTRACT:

Background

Designing trials to reduce treatment duration is important in several therapeutic areas, including tuberculosis and bacterial infections. We recently proposed a new randomised trial design to overcome some of the limitations of standard two-arm non-inferiority trials. This DURATIONS design involves randomising patients to a number of duration arms and modelling the so-called 'duration-response curve'. This article investigates the operating characteristics (type-1 and type-2 errors) of different statistical methods of drawing inference from the estimated curve.

Methods

Our first estimation target is the shortest duration non-inferior to the control (maximum) duration within a specific risk difference margin. We compare different methods of estimating this quantity

SUBMITTER: Quartagno M 

PROVIDER: S-EPMC7851720 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature