Abstract 1311: Planning for health equity in oncology trials: Expectations and feasibility
Authors: Skinner Halcyon G. , Marra Caroline , Alexandrow April I. , Subramaniam Hamsa L. , Nussbaum Nathan C. , Franklin Joseph B. , Simard Edgar P. , Abernethy Amy P. 
Published: March 2024

Achieving diverse representation in oncology studies is an ongoing challenge., Responding to calls to advance health equity in clinical trials, Congress amended the Food Drug and Cosmetic Act to require trial sponsors to submit a “diversity action plan” to the FDA with a study’s protocol. This requirement to plan for diverse trial recruitment drives a need to innovate approaches for site selection and trial recruitment that go beyond mirroring race-ethnicity distributions from the US Census or disease prevalence. We present a novel framework that nests clinical trials in a longitudinal patient registry to achieve diverse representation across multiple domains, evaluate site-selection and recruitment strategies, and examine health equity across the cancer patient journey.

Implementing a registry to support longitudinal data collection (i.e., a cohort study), we establish a continuous view of participant characteristics including demographic and social determinants of health, treatment received, and relevant outcomes. Nesting clinical trials within the structure of the cohort, we can select sites and recruit for diverse representation to achieve equity goals. This framework involves a multi-layer analysis of external population statistics and internal reference registry to gauge the pool of eligible participants and calibrate the sampling strategy and recruitment expectations to the realities of clinical representation. Moreover, where clinical representation differs from population statistics, the registry offers an opportunity to report benchmarks for diversity and compare to site-level and study-level realized enrollment and feasibility.

In conclusion, the path to health equity in oncology trials depends on a capacity to ask and answer the right questions in planning. What specific aspects of diversity are we aiming to capture? How do these aspects impact outcomes? We advocate for a dynamic planning process that continuously reevaluates goals and strategies in the face of enrollment data and evolving population demographics. By utilizing a registry with longitudinal follow-up, we can set forth clear expectations, transparently report on the progress of inclusion efforts, and candidly address feasibility challenges. We present a structured framework for trial sponsors to not only comply with the forthcoming requirement for diversity action plans, but ultimately to advance the goal of equitable cancer care through research that truly reflects the complex intersectional diversity of those impacted by the disease.

Citation Format: Halcyon G. Skinner, Caroline Marra, April I. Alexandrow, Hamsa L. Subramaniam, Nathan C. Nussbaum, Joseph B. Franklin, Edgar P. Simard, Amy P. Abernethy. Planning for health equity in oncology trials: Expectations and feasibility [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1311.