Enrollment disparities in non-Hodgkin lymphoma clinical trials.

Abstract

e18594 Background: Disparities in cancer clinical trials limit the real-world reproducibility of their results while remaining inapplicable to excluded patients (pts) like those living with chronic viral infections. Non-Hodgkin lymphoma (NHL) has an incidence distributed heterogeneously among races and is associated with chronic viral infections such as HIV, Hepatitis B (Hep B) and Hepatitis C (Hep C). Given these epidemiological characteristics, we assessed demographic representation in NHL clinical trials to identify areas for improvement. Methods: Clinicaltrials.gov was queried for NHL trials and specified for completed, interventional, phase 2, 3 & 4 trials, with results and with recruitment in the US. Trials including malignancies other than NHL, with enrollment outside of the US or lacking reported demographics on clinicaltrials.gov or trial publications were excluded. SEER 21 and the 2020 US census were used to calculate incident cases for each specified subgroup. Enrollment fraction (EF) was defined as the number of trial enrollees divided by the estimated US cases in each subgroup. We compared EF between subgroups utilizing odds ratios (OR) with p-value < 0.05 deemed significant. Results: Of 176 trials meeting criteria, 64 (36.4%) reported ethnicity and 79 (44.9%) reported race. EF of Black, Asian/Pacific Islander, American Indian and Hispanic (HSP) pts were significantly lower compared to White and non-HSP pts (Table). Racial minorities were less likely to be enrolled in relapsed/refractory trials (OR 0.31 - 0.57 p < 0.008) compared to White pts but all were equally likely to be enrolled in front-line trials. HSP pts had a lower EF compared to non-HSP pts in both relapsed/refractory and front-line trials (OR 0.57, 0.46 p < 0.0001). Black and HSP pts were also less likely to be enrolled in hematopoietic stem cell transplant (HSCT) trials (OR 0.27, 0.74, p < 0.003). Women had a significantly lower EF compared to men (Table). 150 trials had inclusion/exclusion criteria specific for chronic viral infections: 141 (94%) excluded pts with HIV, 108 (72%) with chronic Hep B and 103 (69%) with Hep C. Conclusions: Our study demonstrates underrepresentation of not only women, but also of Black, Asian/Pacific Islanders, American Indian and HSP pts in NHL trials, especially in relapsing/refractory and HSCT trials. Moreover, pts living with chronic viral infections are systematically excluded by trial criteria. It is essential that trials reporting on safety, toxicity and efficacy represent the true patient population to limit ascertainment bias and improve external validity of results.[Table: see text]