Educational intervention for providers addressing the diversity gap in cervical cancer clinical study participation (579)

Abstract

Objectives: Every year, over 570,000 women worldwide are diagnosed with cervical cancer. Cervical cancer accounts for 7.5% of female cancer deaths, and 85% of those deaths occur in low- to moderate-income countries. In the US, it is estimated that Black women have a 30% higher incidence of cervical cancer than White women. Additionally, Hispanic women are 40% more likely to be diagnosed with cervical cancer than non-Hispanic women. In 2020, the US Food and Drug Administration issued industry guidance for enhancing the diversity of clinical study participants, highlighting the critical need for representative studies that reflect the current US population demographics. This study aims to conduct an educational intervention aimed at cervical cancer investigators and patients to increase ethnocultural diversity in clinical study recruitment in a cervical cancer research program. Methods: This educational intervention implemented a pre-post study design of clinical investigators participating in both global Phase 2 and Phase 3 cervical cancer studies. The Phase 3 clinical study serves as the parent foundational study to the Phase 2 study (ongoing study, NCT04646005), as 77% of the clinical investigators participating in Phase 2 clinical study overlap with the Phase 3 study. The ongoing Phase 2 study will educate investigators on ethnocultural diversity, and the inclusion of the two studies will be compared from pre-intervention (Phase 3) to post-intervention (Phase 2). Education will be provided as a one-time virtual training and a supplementary pamphlet and will cover the incidence and mortality differences across races, current enrollment gaps, barriers to including diverse populations, and guidance for the broader inclusion of women in our sponsored studies. Race and ethnicity demographic data for the Phase 2 trial (post-intervention) will be compared with the Phase 3 trial (pre-intervention) using the chi-square statistical test. Assuming significant results, a Z-test will then be used to assess the proportions of each race and ethnicity group. Objectives: Every year, over 570,000 women worldwide are diagnosed with cervical cancer. Cervical cancer accounts for 7.5% of female cancer deaths, and 85% of those deaths occur in low- to moderate-income countries. In the US, it is estimated that Black women have a 30% higher incidence of cervical cancer than White women. Additionally, Hispanic women are 40% more likely to be diagnosed with cervical cancer than non-Hispanic women. In 2020, the US Food and Drug Administration issued industry guidance for enhancing the diversity of clinical study participants, highlighting the critical need for representative studies that reflect the current US population demographics. This study aims to conduct an educational intervention aimed at cervical cancer investigators and patients to increase ethnocultural diversity in clinical study recruitment in a cervical cancer research program. Methods: This educational intervention implemented a pre-post study design of clinical investigators participating in both global Phase 2 and Phase 3 cervical cancer studies. The Phase 3 clinical study serves as the parent foundational study to the Phase 2 study (ongoing study, NCT04646005), as 77% of the clinical investigators participating in Phase 2 clinical study overlap with the Phase 3 study. The ongoing Phase 2 study will educate investigators on ethnocultural diversity, and the inclusion of the two studies will be compared from pre-intervention (Phase 3) to post-intervention (Phase 2). Education will be provided as a one-time virtual training and a supplementary pamphlet and will cover the incidence and mortality differences across races, current enrollment gaps, barriers to including diverse populations, and guidance for the broader inclusion of women in our sponsored studies. Race and ethnicity demographic data for the Phase 2 trial (post-intervention) will be compared with the Phase 3 trial (pre-intervention) using the chi-square statistical test. Assuming significant results, a Z-test will then be used to assess the proportions of each race and ethnicity group.