DOI: 10.1161/circ.148.suppl_1.12956 ISSN: 0009-7322

Abstract 12956: Novel Digital Strategy for Improving Diversity in Cardiovascular Clinical Trials

Sneha S Jain, Marco V Perez, Kaylin T Nguyen, Adrian F Hernandez, Mintu Turakhia, Kenneth W Mahaffey
  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Background: Diversity of trial participants is crucial for the generalizability of clinical trial findings. Cardiovascular trials often underrepresent non-white participants, women, and older individuals. Investigators for the Apple Heart Study (AHS) and the Project Baseline Health Study (PBHS) used a digital platform or ‘waiting room’ to invite interested individuals in the United States to learn about the study, sign an electronic consent, and provide some baseline information including assessment of key inclusion/exclusion criteria. For AHS, the direct-to-participant approach led to the recruitment of participants that were comparably aligned with the US census. For PBHS, participants were enrolled from a ‘waiting room’ using specific parameters to meet the pre-specified target of mimicking the US census for race and ethnicity.

Methods: We describe the sex, age, and race/ethnicity of the population enrolled in AHS and PBHS. AHS was a completely siteless/virtual trial, while PBHS did traditional assessments at physical locations while also having virtual components.

Results: A total of 419,297 participants were enrolled in just 8 months in the AHS and 2502 were enrolled in PBHS. The sex, age, and race/ethnicity of the study populations are shown (see Table). 42-55% were women, 11.6% were Hispanic, 8-16% were black, 6-10% were Asian and 63-68% were white. AHS enrolled from all 50 states, while PBHS enrolled from 4 locations in California and North Carolina.

Conclusion: In two direct-to-participant clinical trials, we were able to recruit participants that were comparably aligned with the US census. The digital strategies used were successful in both siteless and traditional site-based research studies. The direct-to-participant recruitment approach and digital waiting room are potentially scalable methods for digital recruitment and enrollment to improve diversity in pivotal cardiovascular studies.

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