Breaking down the RECIST 1.1 double read variability in lung trials: What do baseline assessments tell us?

ABSTRACT:

Background

In clinical trials with imaging, Blinded Independent Central Review (BICR) with double reads ensures data blinding and reduces bias in drug evaluations. As double reads can cause discrepancies, evaluations require close monitoring which substantially increases clinical trial costs. We sought to document the variability of double reads at baseline, and variabilities across individual readers and lung trials.

Material and methods

We retrospectively analyzed data from five BICR clinical trials evaluating 1720 lung cancer patients treated with immunotherapy or targeted therapy. Fifteen radiologists were involved. The variability was analyzed using a set of 71 features derived from tumor selection, measurements, and disease location. We selected a subset of readers tha

SUBMITTER: Iannessi A 

PROVIDER: S-EPMC10060958 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature