Nindra Udit, Tang Joanne, Hong Jun Hee, Hong Martin, Teng Christina, Wei Joe, Killen Andrew, Cooper Adam, Wilkinson Kate, Ng Weng, Lemech Charlotte, Chua Wei, Pal Abhijit
Department of Medicine, Western Sydney University, Campbelltown, Australia.
Department of Medical Oncology, Wollongong Hospital, Wollongong, Australia.
JNCI Cancer Spectr. 2025 Mar 3;9(2). doi: 10.1093/jncics/pkaf035.
Early phase clinical trials continue to have difficulty with enrolling real-world populations with many minorities being underrepresented. Reasons for this include patient or clinician perception as well as cultural, linguistic, or social barriers. In Australia, there is currently no prospective data in the early phase clinical trial space regarding recruitment of priority populations.
Patient Diversity in Early Phase Clinical Trials was a multicenter, prospective, cohort study involving 2 major early phase clinical trial centers in Sydney, Australia. All participants who were consented to an early phase clinical trial between August 2023 and August 2024 were enrolled. Participants completed a baseline demographic survey, which included cultural and linguistic status, sexual orientation, socioeconomic status, and regional diversity.
A total of 114 participants were recruited. Median age was 63 years (range = 25-83 years) with predominance for female participants (52%). No participant reported a nonbinary gender. All participants reported their sexuality as heterosexual, with no LGBTQIA+ participants recruited. A total of 34 (30%) participants were identified as culturally diverse, while 28 (25%) were linguistically diverse. One patient identified as Indigenous Australian. Of the participants, 26% were born overseas, with 44% having at least 1 parent born overseas. The majority were living in households with family members, with 8% of participants living alone.
Patient Diversity in Early Phase Clinical Trials is the first prospective study that provides granular description of social, cultural, linguistic, economic, and sexual diversity among early phase clinical trial participants. Certain subgroups are underrepresented, including those with sexual diversity, gender diversity, and Indigenous backgrounds. Ongoing efforts to monitor and promote inclusion of diverse populations in clinical trials are vital.
早期临床试验在招募现实世界人群方面仍然存在困难，许多少数族裔的代表性不足。原因包括患者或临床医生的认知以及文化、语言或社会障碍。在澳大利亚，目前在早期临床试验领域没有关于优先人群招募的前瞻性数据。
“早期临床试验中的患者多样性”是一项多中心、前瞻性队列研究，涉及澳大利亚悉尼的2个主要早期临床试验中心。所有在2023年8月至2024年8月期间同意参与早期临床试验的参与者均被纳入研究。参与者完成了一项基线人口统计学调查，其中包括文化和语言状况、性取向、社会经济地位和地区多样性。
共招募了114名参与者。中位年龄为63岁（范围=25-83岁），女性参与者占多数（52%）。没有参与者报告自己的性别为非二元性别。所有参与者均报告其性取向为异性恋，未招募到LGBTQIA+参与者。共有34名（30%）参与者被确定为文化多元，28名（25%）参与者语言多元。有1名患者被确定为澳大利亚原住民。在参与者中，26%出生在海外，44%至少有1名父母出生在海外。大多数人与家庭成员同住，8%的参与者独自生活。
“早期临床试验中的患者多样性”是第一项前瞻性研究，对早期临床试验参与者的社会、文化、语言、经济和性取向多样性进行了详细描述。某些亚组的代表性不足，包括性取向多元、性别多元和有原住民背景的人群。持续监测并促进临床试验中纳入多样化人群的努力至关重要。
