Evaluating patient diversity in EP-CTs in Australia through a prospective multi-Centre non-randomised cohort study.

Abstract

Background: Early Phase Clinical Trials (EP-CTs) continue to have significant 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 EP-CT space regarding recruitment of priority populations.

Methods: PEARLER (Patient divErsity in eARLy phasE clinical tRials) was a multi-centre, prospective, cohort study involving two major EP-CT centres in Sydney, Australia. All participants who were consented to an EP-CT 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.

Results: One-hundred and fourteen participants were recruited. Median age was 63 years (25-83 years) with predominance for female participants (52%). No participant reported a non-binary gender. All participants reported their sexuality as heterosexual with no LGBTQIA+ participants recruited. 34 participants (30%) were identified as culturally diverse whilst 28 (25%) were linguistically diverse. One patient identified as indigenous Australian. 26% of participants were born overseas with 44% having at least one parent born overseas. The majority were living in households with family members with 8% of participants living alone.

Conclusion: PEARLER is the first prospective study that provides granular description of social, cultural, linguistic, economic and sexual diversity amongst EP-CT participants. Certain subgroups are under-represented 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.