Improving ethnic and racial diversity within clinical trial populations through community recruitment and inclusion initiatives: Experience from MyTACTIC.

Authors

null

Richard Michael Zuniga

OneOncology, Inc., Nashville, TN

Richard Michael Zuniga , David R. Spigel , Lee S. Schwartzberg , Jason Hong , Luke Passler , Walter C. Darbonne , Tania Szado , Ari VanderWalde , Davey Daniel

Organizations

OneOncology, Inc., Nashville, TN, Sarah Cannon Research Institute, Nashville, TN, Renown Health-Pennington Cancer Institute, Reno, NV, US Medical Affairs Oncology, Genentech, Inc., South San Francisco, CA, Clinical Research, West Cancer Center and Research Institute, Germantown, TN

Research Funding

Genentech, Inc.

Background: Clinical trial populations are not typically ethnically diverse, restricting healthcare equity and the generalizability of clinical trial data to real-world populations. Moreover, mostpatients (pts) with cancer in the US receive treatment in the more diverse community setting, where minority groups are usually better represented but with lower trial enrollment rates than academic centers. MyTACTIC (NCT04632992) is a phase II, non-randomized basket trial evaluating targeted therapies in pts with advanced solid tumors with specific biomarkers. Inclusive research practices, including mostly community recruitment, were implemented in MyTACTIC to improve access for patients who may otherwise not have been able to enroll. This retrospective analysis presents their impact on the diversity of the trial population. Methods: Adult pts with advanced solid tumors were enrolled from community cancer clinics (private practices and community hospitals) or large academic centers, into 1 of 15 arms based on biomarker alterations. Inclusive research practices implemented to diversify pt recruitment included: revision of eligibility requirements to be more inclusive for minorities; language simplification and streamlining of study protocol; training activities; free transportation. We compared race and ethnicity data between the study population and trial sites’ catchment area (geographical area of pts around the clinical site). Results: Forty pts, all of White race, were initially enrolled across 14 sites, which prompted additional focus on diversity efforts. The trial was expanded to 45 sites across 21 states: 252 pts were enrolled (83% of White race) (Table). Most (96%) selected sites (n=249 pts) were community clinics. The proportion of pts from racial minorities was generally higher in study centers from ethnically diverse catchment areas. Protocol streamlining and staff training were also beneficial to pt recruitment. Free-ride transportation removed the barrier of access to clinical trial sites. The impact of other initiatives will be presented. Conclusions: Running clinical trials at community oncology sites does not, in itself, equal increased diversity of study populations: other efforts, including but not limited to free transportation and community site selection, are also needed. Here we share some learnings from the MyTACTIC study, based on outcomes from the various inclusive research practices implemented in this trial. Clinical trial information: NCT04632992.

EthnicityMyTACTIC Enrollment Demography (%)Catchment Area (%)
White82.559.0
Black or African American8.714.0
Hispanic or Latino4.416.9
Asian2.48.1
Native Hawaiian or Other Pacific Islander00.4
Unknown2.01.7

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Care Delivery/Models of Care

Track

Care Delivery and Quality Care

Sub Track

Disparities in Care

Clinical Trial Registration Number

NCT04632992

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr e13679)

DOI

10.1200/JCO.2024.42.16_suppl.e13679

Abstract #

e13679

Abstract Disclosures

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