Jones David A, Spencer Katie, Ramroth Johanna, Probert Jake, Roope Laurence S J, Shakir Rebecca, Broggio John, Burroughs Frank, Collins Graham P, Clarke Philip M, Wolstenholme Jane L, Cutter David J
Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Br J Haematol. 2025 Feb;206(2):531-540. doi: 10.1111/bjh.19907. Epub 2024 Nov 27.
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.
试验地点的分布可能导致地理可及性方面的差异，并影响临床试验中患者的代表性。我们利用了来自国家卫生与保健研究机构（NIHR）开放数据平台的1993 - 2022年试验数据、2011年和2021年的英国人口普查数据与地理数据，以及1997年至2017年期间被诊断为淋巴瘤的患者的英国个体患者癌症登记数据。为了评估代表性，我们比较了试验参与者与发病群体之间的患者年龄和性别。我们绘制了英国低层超级输出区（LSOAs）到其最近的开展研究的国民保健服务信托机构的距离和出行时间，并评估了距离和出行时间与LSOAs的地理和社会人口特征之间的关联。试验参与者比发病群体更年轻，且更有可能为男性。超过一半的英国LSOAs距离最近的国民保健服务信托机构并非开展研究的机构。LSOA的平均年龄越大、男性比例越高、英国白人比例越高、乡村性和沿海/边境状态与距离和出行时间呈正相关（在预先设定的p < 0.05水平），而贫困程度越高则呈负相关。英国的女性和老年淋巴瘤患者在试验中的代表性不足，后者面临着更高的地理障碍负担。
