Abstracts

This is a Late Breaking abstract

Rationale: Although race is a social construct without biological significance, data regarding race and ethnicity in biomedical research can inform how and where to focus epilepsy treatment and prevention. Failing to report race ignores this reality and can conceal health disparities. For example, there are known disparities in the recruitment of participants from minoritized communities in clinical trials, which may lead to unclear data about the prevalence of epilepsy along racial and ethnic lines. In addition, the impacts of the social determinants of health may not be fully accounted for when race and ethnicity are not acknowledged in clinical trials. In this study, we conduct a meta-analysis of clinical trials in epilepsy. Our first aim is to evaluate the inclusion of racial data in epilepsy clinical trials. Our second aim is to assess the representation of various races and genders in these trials.

Methods: This meta-analysis consisted of publicly available epilepsy clinical trials of pharmacologic agents using the ClinicalTrials.gov database. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. Two independent reviewers extracted study-level data for this random-effects meta-analysis. A third person served as a tiebreaker on categorization and documentation and performed a random check of study-level data. Microsoft Excel was used for data collection and analysis. The primary outcome is the prevalence of studies that did not incorporate racial data. The secondary outcomes are the prevalence of each racial subgroup (White, Black, Combined Other) and gender subgroup among trials that reported race demographic data.

Results: There were 1767 studies identified using the search term “epilepsy” on Clinical Trials.gov. When filtered by completed interventional trials with results, 276 trials remained. 131 (47%) of the 276 trials included racial data. Analyzing those 131 trials, 48% of the participants were female and 50% were male. Approximately 59% were White, 4% were Black, and 37% were a “combined other” category (Asian, American Indian, Native Hawaiian, other, and unknown/not reported).

Conclusions: A lack of proportionate recruitment across race categories and inconsistent racial reporting can result in inadequate information about how epilepsy affects non-White individuals, including but not limited to: response to treatment, management of symptoms, and adverse effects of medications. Therefore, the risk-benefit ratio may differ in specific populations, compounding any disparities in health outcomes. Nevertheless, 52.5% of epilepsy clinical trials did not include racial data. Of the trials with racial data, we found that Latinx, Black, Asian, American Indian, Native Hawaiian, and other minoritized communities were underrepresented. Diversifying clinical trials would optimize the trial results' generalizability, enhance clinical knowledge of the disease pathology, and promote social justice and health equity. These results warrant further investigation to monitor the ongoing racial disparity in clinical trials.

Funding: None