Approaches to Selecting "Time Zero" in External Control Arms with Multiple Potential Entry Points: A Simulation Study of 8 Approaches.

ABSTRACT:

Background

When including data from an external control arm to estimate comparative effectiveness, there is a methodological choice of when to set "time zero," the point at which a patient would be eligible/enrolled in a contemporary study. Where patients receive multiple lines of eligible therapy and thus alternative points could be selected, this issue is complex.

Methods

A simulation study was conducted in which patients received multiple prior lines of therapy before entering either cohort. The results from the control and intervention data sets are compared using 8 methods for selecting time zero. The base-case comparison was set up to be biased against the intervention (which is generally received later), with methods compared in their ability to estimate the true inte

SUBMITTER: Hatswell AJ 

PROVIDER: S-EPMC9459359 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature