Referral pattern to phase 1 oncology trials is a highly relevant topic as the rapid development of new anticancer agents requires increased recruitment to early clinical trials. In this study, we investigated possible recruitment bias. The objective was to compare the socioeconomic position (SEP) and region of residence of patients referred to the Phase 1 Unit at Copenhagen University Hospital to a matched control group. Moreover, we investigated the influence of SEP on the inclusion in trials.
Data from the Danish registries were compiled based on the civil registration number of patients referred to the Phase I Unit from 2005 to 2016. The association between SEP and referral was examined in a conditional logistic regression analysis based on referred patients and a matched control group. We adjusted for number of cancers, M-stage, comorbidity and psychological disturbances. The association between SEP and enrolment once referred was examined in a Cox regression analysis.
1255 patients were referred. 1143 of these patients were eligible for this study. Complete data for analyses were available for 1026 patients and 229,788 controls matched on age, gender, type of cancer, year of diagnosis and time from diagnosis to referral. As barriers for referral, we identified short education as compared to long (OR 0.57, 95% CI 0.47-0.69), being outside workforce as compared to being within (OR 0.67, 95% CI 0.56-0.80), living alone as compared to living with a partner (OR 0.85, 95% CI 0.74-0.99) and living far from the Phase 1 Unit 0.34 as compared to living close to (95% CI 0.29-0.40). 252 patients enrolled in trials. Once referred, the socioeconomic parameters did not affect enrolment.
In this single-center study, patients’ SEP and region of residence affected referral pattern to phase 1 trials. This suggests inequality in the access to phase 1 trials.
Clinical trial identification
Legal entity responsible for the study
Danish Cancer Society Research Center, Copenhagen, Denmark.
A.P. Møller Foundation, Knæk Cancer funds, The Health Foundation.
All authors have declared no conflicts of interest.