The Importance of Medicaid Data To Improve Diversity in Clinical Trials

Paralleling many conversations across the current socio-political landscape, life sciences have been striving to fix the lack of diversity in clinical trials. This has taken a few different angles ranging from access to representative results.

While these conversations have been ongoing, two recent updates prompted more urgent action: Medicaid became responsible for the costs of clinical trials for Medicaid patients,¹ and the FDA issued guidance requiring clinical trial diversity plans.²

Using real world evidence in the design of a clinical trial allows life science organizations to ensure they meet diversity requirements in advance of beginning the trial, thus reducing the need for subsequent iterations and using resources most efficiently.

Often, conversations around diverse real world evidence data focus on social determinants of health (SDoH), which are critical data points. However, it is also important to start with a diverse data set. Many CareJourney members utilize the 100% CMS Medicaid data set for this reason.

Overall Medicaid enrollment is public, yet for clinical trials it’s important to get as granular as possible, for example:

• Distilling granular geographic levels, like county-level trends
• Profiling Medicaid patient demographics (income, age, race, etc)
• Highlighting indication prevalence
• Assessing linked and longitudinal data to understand more accurate outcomes
• Combining Medicare Advantage, Medicaid, and Medicare FFS cohorts of patients

As an example of what we can learn from the Medicaid data set, see the profile below of Jefferson County, KY, outside the Louisville area, with high overall Medicaid enrollment.

At a high level, we can understand the proportion of the populations across Medicaid FFS, as well as Medicaid Managed Care Organizations. We can also see the breakdown across key Medicaid cohorts.

Examining Medicaid and CHIP enrollment lends insights into a vast population (over 93M lives in January 2023) including children, parents, people who are pregnant, elderly people with certain incomes, and people with disabilities. Medicaid patients can help diversify the recruitment pool of study participants thus increasing the efficacy of clinical trials and potential impact of new and emerging therapies.