Kong Wan Yee, Saber Hamidreza, Marawar Rohit, Basha Maysaa Merhi
Department of Neurology, Wayne State University, Detroit Medical Centre, Michigan University Health Center, 4201 St Antoine A, Detroit, MI, 48201, United States.
Department of Neurology, University of California, Los Angeles 710 Westwood Plaza, Los Angeles, CA, 90095-1769, United States.
Epilepsy Res. 2021 Jul;173:106613. doi: 10.1016/j.eplepsyres.2021.106613. Epub 2021 Mar 11.
To describe the racial and gender distribution in antiseizure medications (ASM) clinical trials using a systemic review of clinical trial registry database.
We searched ClinicalTrials.gov database for ASM trials registered from September 1988 to January 2019. All randomized and non-randomized trials investigating ASM for epilepsy were included. Trials with intervention other than ASM or condition other than epilepsy were excluded. Data on age, race, ethnicity, and gender were extracted directly from database and from published data where available. Study location, trial identifier, year of completion, and funding sources were also collected. Meta-analysis of proportions was conducted using R software.
Two hundred and thirty studies conducted globally with 39,576 participants were included. Overall, there are 53 % male on all registered ASM studies globally. For trials conducted in the United States (61 studies/5126 participants), 52 % of the participants were male with the following weighted racial distribution (80 % White 13 % Black 3% Asian 7% Hispanic). Subgroup analysis revealed that non-pharma-sponsored studies (50 studies, 4296 participants) have a higher representation of minorities as compared to pharma-sponsored studies (180 studies, 35,280 participants), including Hispanic (9% vs 3% respectively) and Black (18 % vs 11 % respectively). Temporal trends in racial distribution were noted when the duration of 2007-2019 was split into two groups: 2007-2013 (0% Asian, 5% Hispanic, 20 % Black); 2014-2019 (4% Asian, 7% Hispanic, 8% Black).
In this systematic review, participation of racial and ethnic minorities of Asian and Hispanic background was under-represented. Disparities of all minorities including Black participants was more notable over time and in studies sponsored by industry. Generalizability of ASM clinical trials to certain subgroups should be further examined.
通过对临床试验注册数据库进行系统评价，描述抗癫痫药物（ASM）临床试验中的种族和性别分布情况。
我们在ClinicalTrials.gov数据库中搜索了1988年9月至2019年1月期间注册的ASM试验。纳入所有研究ASM治疗癫痫的随机和非随机试验。排除了干预措施不是ASM或疾病不是癫痫的试验。有关年龄、种族、民族和性别的数据直接从数据库中提取，并在可获取的情况下从已发表的数据中提取。还收集了研究地点、试验标识符、完成年份和资金来源。使用R软件进行比例的荟萃分析。
纳入了全球开展的230项研究，共39576名参与者。总体而言，全球所有注册的ASM研究中男性占53%。在美国开展的试验（61项研究/5126名参与者）中，52%的参与者为男性，其加权种族分布如下（80%为白人，13%为黑人，3%为亚洲人，7%为西班牙裔）。亚组分析显示，与制药公司资助的研究（180项研究，35280名参与者）相比，非制药公司资助的研究（50项研究，4296名参与者）中少数族裔的代表性更高，包括西班牙裔（分别为9%和3%）和黑人（分别为18%和11%）。当将2007 - 2019年的时间段分为两组时，注意到了种族分布的时间趋势：2007 - 2013年（0%亚洲人，5%西班牙裔，20%黑人）；2014 - 2019年（4%亚洲人，7%西班牙裔，8%黑人）。
在这项系统评价中，亚洲和西班牙裔背景的种族和少数族裔参与度不足。随着时间推移以及在行业资助的研究中，包括黑人参与者在内的所有少数族裔的差异更为显著。应进一步研究ASM临床试验对某些亚组的可推广性。
