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

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 <18years) 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.