Lost in the Plot: Missing Visual Elements in Kaplan-Meier Plots of Phase III Oncology Trials

Authors

Alexander D Sherry
Pavlos Msaouel
Ramez Kouzy
Joseph Abi Jaoude
Timothy A Lin
Cullen M Taniguchi
Clifton David Fuller
Bruce Minsky
Ethan B Ludmir

Publication Date

7-5-2024

Journal

The Oncologist

Abstract

Missing visual elements (MVE) in Kaplan-Meier (KM) curves can misrepresent data, preclude curve reconstruction, and hamper transparency. This study evaluated KM plots of phase III oncology trials. MVE were defined as an incomplete y-axis range or missing number at risk table in a KM curve. Surrogate endpoint KM curves were additionally evaluated for complete interpretability, defined by (1) reporting the number of censored patients and (2) correspondence of the disease assessment interval with the number at risk interval. Among 641 trials enrolling 518 235 patients, 116 trials (18%) had MVE in KM curves. Industry sponsorship, larger trials, and more recently published trials were correlated with lower odds of MVE. Only 3% of trials (15 of 574) published surrogate endpoint KM plots with complete interpretability. Improvements in the quality of KM curves of phase III oncology trials, particularly for surrogate endpoints, are needed for greater interpretability, reproducibility, and transparency in oncology research.

Keywords

Humans, Clinical Trials, Phase III as Topic, Kaplan-Meier Estimate, Neoplasms, Medical Oncology, randomized controlled trials, phase III, Kaplan-Meier, clinical research, data visualization, time-to-event outcomes

Comments

Supplementary Material

Data Availability Statement

PMID: 38824414

DOI

10.1093/oncolo/oyae067

PMID

38824414

PMCID

PMC11224967

PubMedCentral® Posted Date

June 2024

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes