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RESEARCH ARTICLE
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Reporting Indigenous status, ethnicity, language and country of birth to build equity in international paediatric clinical trials with Australian sites: a scoping review

Jacqueline Cunninghame https://orcid.org/0000-0002-9270-793X A B * , Mari Takashima A C , Lorelle Holland A D E , Linda Nguyen A , Abbey Diaz F , Shuaijun Guo G H , Mitchell Dufficy https://orcid.org/0000-0001-9461-801X A , Craig F. Munns D I and Amanda Ullman A C
+ Author Affiliations
- Author Affiliations

A School of Nursing, Midwifery and Social Work, Faculty of Health and Behavioural Sciences, The University of Queensland, St Lucia, Qld, Australia.

B Centre for Children’s Health Research, 62 Graham Street, South Brisbane, Qld 4101, Australia.

C Queensland Children’s Hospital, Children’s Health Queensland Hospital and Health Service, South Brisbane, Qld, Australia.

D Child Health Research Centre, Faculty of Medicine, The University of Queensland, St Lucia, Qld, Australia.

E UQ Poche Centre for Indigenous Health, Faculty of Health and Behavioural Sciences, The University of Queensland, St Lucia, Qld, Australia.

F School of Public Health, Faculty of Medicine, The University of Queensland, St Lucia, Qld, Australia.

G ANU Centre for Social Research and Methods, Australian National University, Canberra, ACT, Australia.

H Centre for Community Child Health, Murdoch Children’s Research Institute, The Royal Children’s Hospital, Melbourne, Vic, Australia.

I Department of Endocrinology, Queensland Children’s Hospital, Children’s Health Queensland Hospital and Health Service, South Brisbane, Qld, Australia.

* Correspondence to: j.cunninghame@uq.edu.au

Australian Health Review https://doi.org/10.1071/AH24184
Submitted: 8 July 2024  Accepted: 11 November 2024  Published: 3 December 2024

© 2024 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.

Abstract

Objective

Ensuring equitable access to clinical trials for children from Indigenous and ethnically and linguistically diverse backgrounds should be central to clinical trial design. This review aims to expansively review the reporting of Indigenous status (Aboriginal and/or Torres Strait Islander origin), ethnicity, culture, location, language and country of birth in paediatric clinical trials with Australian sites.

Methods

This scoping review systematically searched PubMed, CINAHL and Embase for international clinical trials with Australian sites conducted between 2018 and 2022 involving children (aged <18 years) to determine the reporting of Indigenous status, race, ethnicity, language and country of birth.

Results

Of the 262 studies included, 154 (58.8%) clinical trials did not report any of the variables of interest. When reported, terms used by authors were heterogeneous. ‘Indigenous status’ was most reported (n = 40, 15.3%) and self-identification was the most common method to determine this (n = 14, 35.9%). International clinical trials had higher rates of reporting for ethnicity, cultural background and race. Overall, more than 60 terms were used to categorise study participants in relation to ‘Indigenous status’, 'ethnicity and cultural background', ‘race’, ‘race and ethnicity’ or ‘natural skin colour’.

Conclusions

This review demonstrated low rates of reporting of demographic variables in paediatric clinical trials. Clear reporting standards, partnering with consumers to co-design trials and self-identification during collection are required. Ensuring adequate access to clinical trials for Indigenous children and children from ethnically, linguistically and geographically diverse backgrounds is essential in building health equity and ensuring patient safety.

Keywords: clinical trial, equity, Indigenous health, minority health, paediatric, reporting, scoping review.

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