Clinical trial participation for vulnerable cancer patients in Denmark and England

Abstract

Background

New cancer therapies are introduced through clinical trials. However, eligibility criteria can pose a barrier to vulnerable patients, limiting access to potentially improved treatments and reducing generalizability of the results. The aim of this study was to investigate participation in clinical trials for vulnerable cancer patients in Denmark and compare results to England.

Patients and methods

We utilized population-based registries of systemic anti-cancer therapy from the North Denmark Region and England covering, respectively, 2008–2021 and 2016–2019. We included adult patients (≥18 years) who received SACT in relation to a solid cancer. Vulnerability was defined as the lowest quintile in relation to socioeconomic position. We estimated odds ratios (OR) for participation in a clinical trial.

Results

We included 15,173 patients in the Danish cohort and 336,218 in the English. From these 1107 (7.3 %) and 12,502 (3.7 %) participated in a clinical trial, respectively. The adjusted OR for participating in a trial for vulnerable patients was 0.81 (95 % CI 0.68–0.96) in Denmark and 0.80 (95 % CI 0.76–0.84) in England. The strongest associations were found within gynaecological cancers.

Conclusion

We found associations of reduced trial participation for vulnerable individuals in both countries and consistent associations within gynaecological cancers.