Evaluating patient diversity in early phase clinical trials in Australia through a prospective multicenter nonrandomized cohort study

TL;DR

This study examines the diversity of participants in early phase clinical trials in Australia, finding underrepresentation of certain groups like Indigenous Australians and LGBTQIA+ individuals.

Contribution

This is the first prospective study to provide detailed data on diversity in early phase clinical trials in Australia.

Findings

Only 30% of participants were culturally diverse and 25% were linguistically diverse.

No participants identified as LGBTQIA+ or nonbinary, and only one participant was Indigenous Australian.

Ongoing efforts are needed to improve inclusion of underrepresented groups in clinical trials.

Abstract

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.