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; Mari Takashima; Lorelle Holland; Linda Nguyen; Abbey Diaz; Shuaijun Guo; Mitchell Dufficy; Craig Munns; Amanda Ullman

Just Accepted

This article has been peer reviewed and accepted for publication. It is in production and has not been edited, so may differ from the final published form.

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 , Mari Takashima, Lorelle Holland, Linda Nguyen, Abbey Diaz, Shuaijun Guo, Mitchell Dufficy , Craig Munns, Amanda Ullman

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 2018-2022 involving children (aged <18years) to determine the reporting of Indigenous status, race, ethnicity, language and country of birth. Framework. Results: Of 262 studies included, 154 (58.8%) clinical trials did not report any of the variables of interest. When reported, terms used by authors were heterogenous. ‘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 and cultural background, and race. Overall, more than 60 terms were used to categorise study participants in relation to ‘Indigenous status’, ‘race’, ‘race and ethnicity’, or ‘natural skin colour’. Conclusions: This review demonstrated low rates of reporting for 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.

AH24184 Accepted 11 November 2024