Abstract MP23: Clinical and Demographic Factors Influence Clinical Trial Enrollment

Abstract

Introduction: Inclusion of diverse patients in clinical trials is essential to represent patient populations and to ensure that results are generalizable. Analysis of this topic is motivated by prior reports of clinical trials underrepresenting historically disadvantaged groups. We aimed to understand if the clinical trial population is representative of the overall stroke population in our community. Methods: We obtained clinical and demographic data from hospital administrative records including all acute ischemic stroke patients between March 2019 and February 2020. Consent was counted when a signed consent for study participation was documented in the inpatient record. Enrollment in studies with a primary inpatient population at the time of consent (MOST, TIMELESS, ARCADIA, SleepSMART, and STRONG) were included. Patients with consent (CP) and without consent (NCP) were compared using chi-square analysis and t-test probability with SPSS. Results: During the study period, 504 patients met the above criteria; 55 were consented to participate in clinical trials. Overall CP did not differ from NCP in % women (45.5% vs 41.2%, not significant), Hispanic ethnicity, discharge medications, hypertension, diabetes, heart failure, drug and alcohol abuse, atrial fibrillation, and payer (Medicare versus non-Medicare). Median age was lower in CP compared to NCP (63 ± 12.8 vs. 67 ± 13.9, p=.046). The mean NIHSS was lower in CP (6.37 ± 5.95 vs. 8.21 ± 8.91, p=.048). The CP group had lower incidence of prior stroke (9.1% vs. 20.9%, p=.037), less dyslipidemia (12.7% vs. 30.1%, p=.007), fewer comorbidities on average (1.9 ± 1.1 vs. 2.2 ± 1.5, p=.044), was less likely to identify as Asian (0% vs. 8.4%, p=.015) and more likely to identify as white (59.3% vs. 45.7%, p=.045). The CP group was more likely to have migraine (12.7% vs. 1.8% p<.001) and were discharged on more stroke risk-factor modifying medications (2.2 ± .558 vs. 1.9 ± .902, p=.001). Conclusions: While the study population is largely representative, they are more likely to be White, with lower stroke severity, fewer medical comorbidities and less likely to be Asian. We plan to expand this analysis to include more study centers and to guide future clinical trial design.