Childs Sarah, Nindra Udit, Shivasabesan Gowri, Yoon Robert, Haider Sana, Hong Martin, Cooper Adam, Roohullah Aflah, Wilkinson Kate, Chua Wei, Pal Abhijit
Department of Medical Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia.
Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.
Oncology. 2025;103(3):219-226. doi: 10.1159/000540462. Epub 2024 Sep 12.
Early phase clinical trials (EPCTs) enable access to novel therapies for patients who have exhausted standard of care treatment and contribute a crucial role in drug development and research. Culturally and linguistically diverse (CALD) or socially disadvantaged patients have notably lower rates of participation in these trials. We aimed to characterise the social and cultural demographics of patients enrolled on an EPCT in South Western Sydney.
We conducted a 10-year retrospective review of patients enrolled on a EPCT at Liverpool Hospital. CALD patients were defined as those born overseas or whose preferred language was other than English. The patient residential address was used to calculate distance travelled, and the Index of Relative Socioeconomic Disadvantage (IRSD) and Index of Relative Socioeconomic Advantage and Disadvantage (IRSAD) scores were calculated and used as a surrogate for socioeconomic status (SES).
Our study included 233 patients across 39 EPCTs. Ninety-one patients (39%) were identified as CALD. The median IRSD and IRSAD scores were 941 and 944, respectively, with 62.7-67.4% of patients residing in an area with greater disadvantage compared to the median of Australia. The median distance travelled was 17 kilometres with only 12% of participants travelling more than 50 km. CALD patients were more likely to reside in an area of low SES (OR 3.4, 95% CI: 1.8-6.5, p < 0.01) and travelled shorter median distances (10 vs. 23 km) when compared to non-CALD patients.
Our study cohort contained a lower proportion of CALD patients and a higher SES than what we might have expected from our local population. Furthermore, there was a trend toward greater SES disadvantage (lower IRSD/IRSAD scores) for the CALD population. This study provides novel Australian data to support the underrepresentation of culturally diverse or disadvantaged patients on EPCTs. Future efforts should be made to reduce barriers to participation and improve equity in clinical trial participation.
早期临床试验（EPCTs）使那些已用尽标准治疗方案的患者能够获得新的治疗方法，并在药物开发和研究中发挥关键作用。文化和语言多元化（CALD）或社会弱势患者参与这些试验的比例明显较低。我们旨在描述悉尼西南部一项早期临床试验中入组患者的社会和文化人口统计学特征。
我们对利物浦医院一项早期临床试验中入组的患者进行了为期10年的回顾性研究。CALD患者定义为出生在海外或首选语言不是英语的患者。使用患者居住地址计算出行距离，并计算相对社会经济劣势指数（IRSD）和相对社会经济优势与劣势指数（IRSAD）得分，并将其用作社会经济地位（SES）的替代指标。
我们的研究纳入了39项早期临床试验中的233名患者。91名患者（39%）被确定为CALD。IRSD和IRSAD得分的中位数分别为941和944，与澳大利亚中位数相比，62.7%-67.4%的患者居住在劣势更大的地区。出行距离的中位数为17公里，只有12%的参与者出行超过50公里。与非CALD患者相比，CALD患者更有可能居住在社会经济地位较低的地区（OR 3.4，95%CI：1.8-6.5，p<0.01），且出行距离中位数较短（10公里对23公里）。
我们的研究队列中CALD患者的比例低于预期，且社会经济地位高于我们当地人群。此外，CALD人群存在社会经济劣势更大（IRSD/IRSAD得分更低）的趋势。本研究提供了新的澳大利亚数据，以支持文化多元或弱势患者在早期临床试验中代表性不足的情况。未来应努力减少参与障碍，提高临床试验参与的公平性。
