Inequalities in geographic barriers and patient representation in lymphoma clinical trials across England.

in British journal of haematology by David A Jones, Katie Spencer, Johanna Ramroth, Jake Probert, Laurence S J Roope, Rebecca Shakir, John Broggio, Frank Burroughs, Graham P Collins, Philip M Clarke, Jane L Wolstenholme, David J Cutter

TLDR

  • The study found that clinical trial participants in England are often younger and more male than the general population with lymphoma.
  • Geographic barriers and underrepresentation of older women and rural populations are major issues.
  • Researchers should work to make clinical trials more accessible and inclusive to better represent the patient population.

Abstract

The distribution of trial site locations may lead to disparities in geographic access and affect patient representativeness in clinical trials. We utilised trial data covering 1993-2022 from the National Institute for Health and Care Research (NIHR) Open Data Platform, 2011 and 2021 English Census and geographic data and English individual-patient cancer registry data for patients diagnosed with lymphoma between 1997 and 2017. To assess representation, we compared patient age and sex between trial participants and the incident population. We mapped the distance and travel times of English lower layer super output areas (LSOAs) to their nearest research active NHS Trusts and assessed associations between distance and travel times and the geographic and sociodemographic characteristics of the LSOAs. Trial participants were younger than the incident population and more likely to be male. The closest NHS Trust to more than half of English LSOAs was not research active. Greater LSOA mean age, male percent, White British percent, rurality and coastal/border status were positively associated with distance and travel time (at prespecified p < 0.05 level), while greater deprivation was negatively associated. Female and older lymphoma patients in England are underrepresented in trials, with the latter facing a higher burden of geographic barriers.

Overview

  • The study aimed to investigate the representativeness of patients enrolled in lymphoma clinical trials in England, focusing on age, sex, and geographic accessibility.
  • The study used data from the National Institute for Health and Care Research (NIHR) Open Data Platform, English Census, and individual-patient cancer registry data.
  • The researchers mapped the distance and travel times between lower layer super output areas (LSOAs) and their nearest research active NHS Trusts to assess associations with sociodemographic characteristics.

Comparative Analysis & Findings

  • Trial participants were younger than the incident population and more likely to be male.
  • The closest NHS Trust to more than half of English LSOAs was not research active.
  • Greater LSOA mean age, male percent, and rurality were positively associated with distance and travel time, while greater deprivation was negatively associated.

Implications and Future Directions

  • The study highlights the need for more inclusive recruitment strategies in clinical trials to better represent the patient population.
  • Future research should focus on addressing geographic barriers and increasing diversity in trial participants.
  • The findings may inform the development of tailored interventions to improve patient representation and accessibility in clinical trials.
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