Black women are underrepresented in gynecologic cancer clinical trials despite disproportionately worse cancer outcomes

Survey-based ‘return of value’ items show trial design factors that increase desire to participate among Black individuals

Gynecologic cancer clinical trials lack facilitators, information, and results Black individuals perceive as most valuable

Lack of valuable facilitators, information, and results may contribute to low accrual of Black women in cancer research

The results can be used to create person-centered, community-informed clinical trial design for gynecologic cancer research

Underrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals.

ClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations.

279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001–2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration.

Gynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.

Cancer disparities

Gynecologic oncology

Clinical trials

Black women

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