Impact of the timing of tumor assessments on median progression-free survival in clinical trials in advanced cancer patients.

ABSTRACT:

Background

Survival-based surrogate endpoints such as progression-free survival (PFS) are commonly used in oncology clinical trials. The evaluation-time bias in the assessment of median disease progression in randomized trials has been suggested by several simulation studies, but never demonstrated in the clinic. We aimed to demonstrate the existence of potential evaluation-time bias by assessing the impact of the timing of tumor assessments on median PFS from control arms without any active treatment of randomized controlled trials involving advanced cancer patients.

Materials and methods

A systematic literature search of English language publications from 1 January 2000 to 7 January 2021 was performed using MEDLINE (PubMed). Eligible trials for our meta-analysis included a

SUBMITTER: Samaille T 

PROVIDER: S-EPMC8733185 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature