A hybrid approach of handling missing data under different missing data mechanisms: VISIBLE 1 and VARSITY trials for ulcerative colitis

Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing data to determine endpoint status are considered treatment failures, is widely used to handle missing data for dichotomous efficacy endpoints in inflammatory bowel disease (IBD) trials. However, it does not consider the mechanisms leading to missing data and can potentially underestimate the treatment effect.

Source: Contemporary Clinical Trials - November 22, 2020 Category: Radiology Authors: Jingjing Chen, Sharon Hunter, Krisztina Kisfalvi, Richard A. Lirio Source Type: research