Informative censoring in externally controlled clinical trials: a potential source of bias.

ABSTRACT:

Background

Cancer researchers frequently consider the use of single-arm and randomized controlled clinical trial designs that leverage external data. The literature has reported extensively on how the use of external data can introduce bias through a variety of distortion mechanisms. In this article, we focus on a distortion mechanism that is often overlooked: informative censoring. Informative censoring arises when there is statistical dependence between patients' censoring times and survival times.

Materials and methods

We used simulations to investigate how informative censoring of external controls (ECs) can influence the results of cancer clinical trials. Our simulations included the following: (i) model-based replicates of clinical trials and in silico glioblastoma tri

SUBMITTER: Rudra Gupta T 

PROVIDER: S-EPMC11758402 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature