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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.

References

1  Cunningham J, Garvey G. Are there systematic barriers to participation in cancer treatment trials by Aboriginal and Torres Strait Islander cancer patients in Australia? Aust N Z J Public Health 2021; 45(1): 39-45.
| Crossref | Google Scholar | PubMed |

2  Greenberg RG, McCune S, Attar S, Hovinga C, Stewart B, Lacaze-Masmonteil T. Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children. Ther Innov Regul Sci 2022; 56(6): 934-47.
| Crossref | Google Scholar | PubMed |

3  Joseph PD, Craig JC, Caldwell PHY. Clinical trials in children. Br J Clin Pharmacol 2015; 79(3): 357-69.
| Crossref | Google Scholar | PubMed |

4  Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Community 2004; 12(5): 382-8.
| Crossref | Google Scholar | PubMed |

5  Gross AS, Harry AC, Clifton CS, Della Pasqua O. Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response. Br J Clin Pharmacol 2022; 88(6): 2700-17.
| Crossref | Google Scholar | PubMed |

6  Oh S, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med 2015; 12(12): e1001918.
| Crossref | Google Scholar | PubMed |

7  Borrell LN, Elhawary JR, Fuentes-Afflick E, Witonsky J, Bhakta N, Wu AHB, et al. Race and Genetic Ancestry in Medicine — A Time for Reckoning with Racism. N Engl J Med 2021; 384(5): 474-80.
| Crossref | Google Scholar | PubMed |

8  Flanagin A, Frey T, Christiansen SL,, AMA Manual of Style Committee. Updated Guidance on the Reporting of Race and Ethnicity in Medical and Science Journals. JAMA 2021; 326(7): 621-7.
| Crossref | Google Scholar | PubMed |

9  Eneanya ND, Boulware LE, Tsai J, Bruce MA, Ford CL, Harris C, et al. Health inequities and the inappropriate use of race in nephrology. Nat Rev Nephrol 2022; 18(2): 84-94.
| Crossref | Google Scholar | PubMed |

10  Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol 2019; 44(5): 148-72.
| Crossref | Google Scholar | PubMed |

11  Fawzy A, Wu TD, Wang K, Robinson ML, Farha J, Bradke A, et al. Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern Med 2022; 182(7): 730-8.
| Crossref | Google Scholar | PubMed |

12  Sharif MZ, Maghbouleh N, Baback Boozary AS. COVID-19 Disparities Among Arab, Middle Eastern, and West Asian Populations in Toronto: Implications for Improving Health Equity Among Middle Eastern and North African Communities in the United States. Health Promot Pract 2024; 25(4): 531-36.
| Crossref | Google Scholar | PubMed |

13  Bhavani SV, Wiley Z, Verhoef PA, Coopersmith CM, Ofotokun I. Racial Differences in Detection of Fever Using Temporal vs Oral Temperature Measurements in Hospitalized Patients. JAMA 2022; 328(9): 885-6.
| Crossref | Google Scholar | PubMed |

14  Corbie-Smith G, St. George DMM, Moody-Ayers S, Ransohoff DF. Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities. J Clin Epidemiol 2003; 56(5): 416-20.
| Crossref | Google Scholar | PubMed |

15  Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Reg Health - Americas 2022; 11: 100252.
| Google Scholar |

16  Durant RW, Wenzel JA, Scarinci IC, Paterniti DA, Fouad MN, Hurd TC, et al. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer 2014; 120: 1097-105.
| Crossref | Google Scholar | PubMed |

17  Lund MJ, Eliason MT, Haight AE, Ward KC, Young JL, Pentz RD. Racial/ethnic diversity in children’s oncology clinical trials. Cancer 2009; 115(16): 3808-16.
| Crossref | Google Scholar | PubMed |

18  Nipp RD, Hong K, Paskett ED. Overcoming barriers to clinical trial enrollment. Am Soc Clin Oncol Educ Book 2019; Vol. 39: 105-14.
| Google Scholar |

19  United Nations. Transforming our World: The 2030 Agenda for Sustainable Development: United Nations. 2015. Available at https://sdgs.un.org/2030agenda

20  United Nations. Universal Values Principle Two: Leave No One Behind: United Nations. 2023. Available at https://unsdg.un.org/2030-agenda/universal-values/leave-no-one-behind#:~:text=Universal%20Values&text=It%20represents%20the%20unequivocal%20commitment,of%20humanity%20as%20a%20whole

21  Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 2009; 62(10): e1-34.
| Crossref | Google Scholar | PubMed |

22  Veritas Health Innovation. Covidence systematic review software Melbourne, Australia; 2019. Available at www.covidence.org.

23  Higgins JPT, James T, Chandler J, Cumpston M, Li T, Page MJ, Welch VA. Cochrane Handbook for Systematic Reviews of Interventions. Cochrane; 2023.

24  Airtable. Digital operations for the AI era. 2012. Available at https://www.airtable.com/

25  Saatci D, Ranger TA, Garriga C, Clift AK, Zaccardi F, Tan PS, et al. Association Between Race and COVID-19 Outcomes Among 2.6 Million Children in England. JAMA Pediatr. 2021; 175(9): 928-38.
| Crossref | Google Scholar | PubMed |

26  Priest N, Thurber KA, Maddox R, Jones R, Truong M. COVID-19 racism is making kids sick. Insight+; 2020. Available at https://insightplus.mja.com.au/2020/18/covid-19-racism-is-making-kids-sick/

27  Wallace N, O’Keeffe S, Gardner H, Shiely F. Underrecording and underreporting of participant ethnicity in clinical trials is persistent and is a threat to inclusivity and generalizability. J Clin Epidemiol 2023; 162: 81-9.
| Crossref | Google Scholar | PubMed |

28  Hirano SA, Murray SB, Harvey VM. Reporting, Representation, and Subgroup Analysis of Race and Ethnicity in Published Clinical Trials of Atopic Dermatitis in the United States Between 2000 and 2009. Pediatr Dermatol 2012; 29(6): 749-55.
| Crossref | Google Scholar | PubMed |

29  Lu C, Ahmed R, Lamri A, Anand SS. Use of race, ethnicity, and ancestry data in health research. PLoS Global Public Health 2022; 2(9): e0001060.
| Crossref | Google Scholar | PubMed |

30  Vale CL, Thompson LC, Murphy C, Forcat S, Hanley B. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey. Trials 2012; 13(1): 9.
| Crossref | Google Scholar | PubMed |

31  Schulz K, Altman D, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010; 8: 18.
| Google Scholar | PubMed |

32  National Health and Medical Research Council. Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities. 2018. Available at https://www.nhmrc.gov.au/about-us/resources/ethical-conduct-research-aboriginal-and-torres-strait-islander-peoples-and-communities