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Abstract Details

Gender and Racial Disparity in Antiepileptic Drug(AED) Trials– A metaanalysis and systematic review of AED randomized controlled trials and open labels studies
Epilepsy/Clinical Neurophysiology (EEG)
P12 - Poster Session 12 (12:00 PM-1:00 PM)
12-007
We seek to investigate disparity of racial and gender enrolment in AED trial in this comprehensive review
The National Institutes of Health (NIH) Revitalization Act 1993 was signed to establish guidelines for inclusion women and minorities in all aspect of clinical research. However, the true effect of the Act is unclear. A study in Washington DC found that lifetime prevalence of epilepsy in White (W)and Black (B) is 0.77% and 2.13%, respectively, with little data on Asian (A) and Hispanic (H).  This further emphasizes the importance of equal gender and racial representation in AED trials.  To our knowledge, there is yet to be any review in the literature on disparity of racial and gender enrolment in AED trials
We search ClinicalTrials.gov and Aggregate Analysis of ClincalTrials.gov database for all AED trials registered from 1988 to 2019. All randomized controlled trial and open label studies with AED intervention and available results are included for data extraction. Statistical analysis is performed using R, and metaanalysis of proportions are conducted.
230 studies are included. Overall, there are 53% male(M) on all registered AED studies globally. For US AED studies, there are 52% M with the following weighted racial distribution (80%W 13%B 3%A 7%H). Subgroup analysis revealed that non pharma sponsored studies has a higher representations of minorities as compared to pharma sponsored studies, including Hispanic 9% vs 3% and Black 18% vs 11%. Additional differences were also noted depending on year of study, 2007-2013 (0%A, 5%H, 20%B); 2014-2019 (4%A, 7%H, 8%B).
Our study revealed no gender disparity in AED clinical trials. However, the is still significant disparities in racial representation with study type and study year both being contributory factors.  
Authors/Disclosures
Wan Yee Kong, MBBS (DMC)
PRESENTER 		Dr. Kong has nothing to disclose.
Hamidreza Saber, MD (Detroit Medical Center/Wayne State Univ Sch Medicine) No disclosure on file
Maysaa M. Basha, MD, FÂ鶹´«Ã½Ó³»­ (Wayne State University, Detroit Medical Center) Dr. Basha has nothing to disclose.