817P - A systematic review of recruitment of ethnic minorities to RCTs of systemic anti-cancer therapies in gynaecological cancers

Background

Emerging evidence suggests pharmacogenomic differences between ethnic groups contributes to disparate treatment effects in cancer patients treated with systemic anti-cancer therapies (SACT). It is important to understand the representation of ethnic minority groups in research, and how this relates to patient outcomes. This systematic review compared participation of ethnic minority groups in contemporary gynae-oncology RCTs of SACT, and described the global distribution of research sites.

Methods

Medline, Embase and ClinicalTrials.gov databases were systematically searched. Phase II & III RCTs of SACT for ovarian, cervical, endometrial, vaginal and vulvar cancers of any stage, published 01/11/2012-01/11/2022 and reporting ethnicity were included. SACT licensed at time of search were eligible. Studies of non-systemic agents, vaccines, radiotherapy or surgery alone were excluded. Outcomes were recruitment by ethnicity and location of research sites. Recruitment by ethnicity was extracted, participation calculated for each group and compared by indication, trial phase and publication period, as well as to incidence in real-world populations. PRISMA guidance was used to report results.

Results

26 RCTs met inclusion criteria. 17,041 patients participated; 79.8% (13,595) were “Caucasian”, 9,1% (1552) “Asian”, 3.7% (630) “Black/African American”, and 6.1% (1,031) “Other/Unknown”. The remaining 1.3% (233) comprised other groups. “Caucasian” patients were over-represented in RCTs for each disease indication, and recruited at a higher rate to phase II than phase III RCTs. “Black/African American” patients recruited at a lower rate to phase III than phase II RCTs.Of 26 studies, 20 were conducted in multiple countries, 5 only in the US, and 1 only in Italy. Of 5478 sites, 4,390 (80.1%) were located in North America or Europe, 187 (3.4%) in East Asia, and 901 (16.5%) in other regions. Notably, no sites were located in Africa or South Asia.

Conclusions

Ethnic minorities are under-represented in contemporary gynae-oncology RCTs. Efforts must be made to include ethnic minority patients to ensure findings are generalisable to real-world populations.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

K. Man: Financial Interests, Institutional, Research Funding: UK National Institute for Health and Care Research, Hong Kong Research Grant Council, CW Maplethorpe Fellowship, European Commission Framework Horizon 2020 , Innovation and Technology Commission of the Government of the Hong Kong Special Administrative Region; Financial Interests, Personal, Funding: IQVIA Ltd. S. Nicum: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Clovis; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Stocks/Shares: GSK; Financial Interests, Institutional, Funding: AstraZeneca. All other authors have declared no conflicts of interest.