Faculty Collaboration Database

Characterization of Underrepresented Populations in Modern Era Clinical Trials Involving Radiation Therapy. Pract Radiat Oncol 2021;11(6):453-459

Date

11/08/2021

Pubmed ID

34742459

DOI

10.1016/j.prro.2021.03.012

Scopus ID

2-s2.0-85118502646 (requires institutional sign-in at Scopus site)   8 Citations

Abstract

PURPOSE: The demographic composition of modern radiation therapy (RT) clinical trials is incompletely studied. Understanding and minimizing disparities in clinical trials is critical to ensure health equity and the generalizability of research findings.

METHODS AND MATERIALS: Clinicaltrials.gov was searched to identify RT clinical trials that occurred from 1996 to 2019. A total of 1242 trials were reviewed for patient characteristics. The demographic composition of the studies was summarized by the frequency and percentage of patients by race, gender, and ethnicity. The racial composition of the study population was compared with the 2018 US Census using a 1-sample χ² test. Subgroup racial composition was compared using χ² tests of independence. Analyses used a complete case approach.

RESULTS: A total of 122 trials met the inclusion criteria, and 121 of these (99.1%) reported race. Trial subgroups included 63 trials in the United States (51.6%), 9 proton therapy trials (7.4%), 34 RT toxicity mitigation or prevention trials (27.9%), 24 trials for female cancer (19.7%), and 17 trials for male cancer (13.9%). US clinical trials overall, US RT toxicity mitigation or prevention trials, US trials for female cancer, and US trials for male cancer had significantly different racial compositions compared with the 2018 US Census data (P < .001 for all). Compared with all clinical trials, those for proton therapy had the largest magnitude of significantly lower enrollment of participants who identified their race as Black, Asian, or other (P < .001).

CONCLUSIONS: This study characterized the racial composition of prospective RT clinical trials in a modern cohort. The racial population represented across multiple categories in the United States differed significantly from US census data and was most pronounced in trials evaluating proton therapy. This is a benchmark study for future efforts to characterize and balance the participation of underrepresented populations in RT clinical trials.

Author List

Bero EH, Rein LE, Banerjee A, Straza MW, Lawton CAF, Schultz CJ, Erickson BA, Siker ML, Hall WA

Authors

Anjishnu Banerjee PhD Associate Professor in the Data Science Institute department at Medical College of Wisconsin
Beth A. Erickson MD Professor in the Radiation Oncology department at Medical College of Wisconsin
William Adrian Hall MD Chair, Professor in the Radiation Oncology department at Medical College of Wisconsin
Lisa E. Rein Biostatistician III in the Data Science Institute department at Medical College of Wisconsin
Christopher J. Schultz MD Professor in the Radiation Oncology department at Medical College of Wisconsin
Malika L. Siker MD Associate Dean, Professor in the Radiation Oncology department at Medical College of Wisconsin
Michael W. Straza MD, PhD Assistant Professor in the Radiation Oncology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Clinical Trials as Topic
Female
Humans
Male
Neoplasms
Prospective Studies
Research Design
United States