Lung cancer enrollment of demographic subgroups in US clinical trial sites
Abstract
8095
Background:
Most clinical trials globally are not representative of a diverse patient population and 78% of trial participants remain White. This may limit the generalizability of trial results to the broader population, create an insufficient understanding of drugs’ safety and efficacy between different patient populations, and hinder equitable access to investigational drugs. We compare the racial and ethnic composition of US clinical trials sites for lung cancer to epidemiology data.
Methods:
The de-identified data was sourced from Medidata’s clinical trial database. The cohort included clinical trial participants enrolled in US sites in phase 1-3 interventional lung cancer studies conducted between 2016 and 2022. Lung cancer incidence estimates were taken from the National Cancer Institute’s incidence data. Sites were classified as at/above or below expected demographic composition based on a relative ratio calculation, RR = proportion of trial patients/proportion of population with lung cancer. RR ≥1 means site recruited at/above expected ratio for the demographic group and vice versa. A 10% tolerance was used to capture minor deviations. A Mann-Whitney U test was used to determine if the two site types have statistically different enrollment rates, with a p-value of 0.05 for significance.
Results:
The analysis cohort consisted of 6,988 lung cancer patients from 85 studies and 876 US sites. Most sites enrolled White non-Hispanic patients at/above the…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6,988 participants or records.
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