Impact of tumour size measurement inter-operator variability on model-based drug effect evaluation.

ABSTRACT:

Purpose

During oncology clinical trials, tumour size (TS) measurements are commonly used to monitor disease progression and to assess drug efficacy. We explored inter-operator variability within a subset of a phase III clinical trial conducted from August 1995 to February 1997 and its impact on drug effect evaluation using a tumour growth inhibition model.

Methods

One hundred twenty lesions were measured twice at each time point; once at the hospital and once at the centralised centre. A visual analysis was performed to identify trends within the profiles over time. Linear regression and relative error ratios were used to explore the inter-operator variability of raw TS measurements and model-based estimates.

Results

While correlation between patient-level estimates o

SUBMITTER: Lombard A 

PROVIDER: S-EPMC7125250 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature