2023 American Academy of Neurology Abstract Website

Objective:

To promote diversity, equity, and inclusion (DEI) in clinical trials through remote research practices

Background:

Clinical trials tend to disproportionately enroll white, male subjects calling into question the generalizability of these studies. The University of Minnesota Stroke Program has helped pioneer telemedicine and remote research practices in stroke clinical trials in collaboration with NIH Stroke Trials Network. This infrastructure supports 24-7 study recruitment that is directly integrated into clinical practice and informs an internal culture of approaching all eligible patients for participation in clinical trials without internal selection bias.

Design/Methods:

We retrospectively reviewed all enrollments in three Phase-III acute stroke clinical trials (NCT03735979, NCT03785678, NCT02864953) enrolled at our tertiary stroke center (Fairview Southdale Hospital) from June 30, 2019 - April 30, 2022. We compared demographics (age, gender, race, ethnicity, and primary language [English: yes/no]) of cohort enrolled in clinical trials versus demographics of general stroke patient population utilizing chi-squared testing and descriptive statistics.

Results:

Sixty-eight patients were enrolled in acute stroke trials (34 in MOST,30 in TIMELESS, 4 in CHARM) with a median age of 71 (IQR 20.25) at Fairview Southdale Hospital.

Race Enrollment Patient Population

White 86.76% (59) 86.7% (2282)

Black/African

American 5.88% (4) 5.7% (149)

Asian 4.41% (3) 3% (79)

Others 1.47% (1) 4.6% (121)

Language Enrollment Patient population

English 94.1% (64) 96.6% (2526)

Somali 2.94% (2) 0.535% (14)

Vietnamese 1.47% (1) 0.46% (12)

Others 1.47% (1). 2.5% (63)

Ethnicity Enrollment Patient Population

Non-Hispanic 94.1% (64) 79.51% (2079)

Hispanic or Latino 1.47% (1) 1.68% (44)

Others/Unknown 4.41% (3) 18.81% (492)

Gender Enrollment Patient Population

Male 51% (35) 47% (1496)

Female 49% (33) 53% (1688)

Conclusions:

We found no notable differences in gender, race, and ethnicity between our clinical trial and non-clinical trial stroke cohorts. Remote research practices eliminates inherent selection bias in clinical research teams and may reduce disparities in clinical trial representation.