116: Addressing Disparities in Clinical Trial Participation: A Comparative Analysis of Cardiovascular & Oncology Studies

Statement of Purpose, Innovation or Hypothesis: Regulatory authorities such as the FDA have underscored the importance of enhancing the representativeness of clinical trial populations to more accurately mirror the demographics of potential medication users. The assurance of diversity and representation among clinical trial participants is crucial for the applicability of trial findings across various population groups. Addressing disparities in trial participation can augment the reliability and relevance of trial results.

Description of Methods & Materials: In this analysis, we scrutinized data from two leading causes of death among all adults in the U.S., cardiovascular disease and cancer, which disproportionately impact certain minority groups. We examined data from all completed trials listed on clinicaltrials.gov from 2000 to 2023 related to cardiovascular disease and cancer. The aim of this analysis was to evaluate demographic representation within clinical trials, contrasting it with general population demographics. This comparison allows us to identify potential disparities and suggest strategies for improving trial enrollment practices. It’s important to note that while some studies provided comprehensive demographic data, others only offered gender breakdowns. This discrepancy could potentially result in lower totals for certain demographic categories due to data availability.

Data & Results: Our analysis covered 5,492 cardiovascular and 10,328 oncology studies, involving over 30.6 million participants. These diseases, leading causes of death in the U.S., disproportionately affect certain minority groups. For instance, the heart disease death rate is 1.3 times higher for Black non-Hispanic Americans than Non-Hispanic White Americans. Additionally, Hispanic/Latinx, Black and Asian American adults are all more likely than white adults to develop diabetes. Black Americans have a higher risk for hypertension than whites, likely due to social determinants of health. Similarly, certain racial and ethnic minorities bear a higher burden of coronary heart disease and stroke mortality. Black Americans have a cancer 19% higher than their white counterparts. These disparities underline the need for targeted interventions and improved public health policies. Further data analysis could inform better treatment strategies and improve patient outcomes.

Interpretation, Conclusion or Significance: Our findings emphasize the critical need for diversity in clinical trials. Disparities in trial participation, especially among historically underrepresented minorities, challenge the validity of trial outcomes and equitable healthcare. These groups find themselves underrepresented in studies on heart disease and cancer in spite of the fact that they are disproportionately affected by these ailments. Current misrepresentation can compound the effect of these groups' historical lack of inclusion Furthermore, poor representation in studies leads these minority groups to distrust the clinical trial process and are less likely to participate in clinical studies. This cycle amplifies the effect of underrepresentation in trials. However, this effect means that the effect of diversity initiatives will naturally compound itself as they work to break the cycle. Therefore, improving enrollment practices to boost participation from diverse demographic groups is imperative. This will foster more inclusive research, leading to reliable and applicable trial outcomes, ultimately benefiting all population groups. Enhancing diversity in clinical trials is not just a goal, but a necessity for the future of healthcare.

Disclosures:

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Additional Information/Authors: Manu Datta, Patrick Valdivia