来自边缘化种族和族裔群体的参与者招募：对STEADY-PD III和SURE-PD3试验的比较评估。
Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials.
作者信息
Di Luca Daniel G, Macklin Eric A, Hodgeman Karen, Lopez Gisel, Pothier Lindsay, Callahan Katherine F, Lowell Jill, Chan James, Videnovic Aleksandar, Lungu Codrin, Lang Anthony E, Litvan Irene, Schwarzschild Michael A, Simuni Tatyana
机构信息
Edmond J. Safra Program in Parkinson's Disease (DGDL, AEL), Movement Disorders Clinic, Krembil Brain Institute, Toronto Western Hospital; Institute of Health Policy (DGDL), Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Biostatistics Center (EAM, JC), Massachusetts General Hospital; Harvard Medical School (EAM, AV, MAS), Boston, MA; University of Rochester Medical Center (KH, JL), NY; Department of Neurology (GL, LP, KFC, AV, MAS), Massachusetts General Hospital, Boston; Division of Clinical Research (CL), National Institute of Neurological Disorders and Stroke, Bethesda, MD; University of California San Diego (IL), CA; and Northwestern University Feinberg School of Medicine (TS), Chicago, IL.
出版信息
Neurol Clin Pract. 2023 Feb;13(1):e200113. doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18.
BACKGROUND AND OBJECTIVES
Representation of persons from marginalized racial and ethnic groups in Parkinson disease (PD) trials has been low, limiting the generalizability of therapeutic options for individuals with PD. Two large phase 3 randomized clinical trials sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), STEADY-PD III and SURE-PD3, screened participants from overlapping Parkinson Study Group clinical sites under similar eligibility criteria but differed in participation by underrepresented minorities. The goal of this research is to compare recruitment strategies of PD participants belonging to marginalized racial and ethnic groups.
METHODS
A total of 998 participants with identified race and ethnicity consented to STEADY-PD III and SURE-PD3 from 86 clinical sites. Demographics, clinical trial characteristics, and recruitment strategies were compared. NINDS imposed a minority recruitment mandate on STEADY-PD III but not SURE-PD3.
RESULTS
Ten percent of participants who consented to STEADY-PD III self-identified as belonging to marginalized racial and ethnic groups compared to 6.5% in SURE-PD3 (difference = 3.9%, 95% confidence interval [CI] 0.4%-7.5%, value = 0.034). This difference persisted after screening (10.1% of patients in STEADY-PD III vs 5.4% in SURE-PD 3, difference = 4.7%, 95% CI 0.6%-8.8%, value = 0.038).
DISCUSSION
Although both trials targeted similar participants, STEADY-PD III was able to consent and recruit a higher percentage of patients from racial and ethnic marginalized groups. Possible reasons include differential incentives for achieving minority recruitment goals.
TRIAL REGISTRATION INFORMATION
This study used data from The Safety, Tolerability, and Efficacy Assessment of Isradipine for Parkinson Disease (STEADY-PD III; NCT02168842) and the Study of Urate Elevation in Parkinson's Disease (SURE-PD3; NCT02642393).
背景与目的
帕金森病（PD）试验中，来自边缘化种族和族裔群体的参与者比例一直较低，这限制了PD患者治疗方案的普遍适用性。由美国国立神经疾病与中风研究所（NINDS）资助的两项大型3期随机临床试验，即稳定型帕金森病研究III（STEADY-PD III）和帕金森病尿酸升高研究（SURE-PD3），在相似的入选标准下，对来自帕金森研究组重叠临床站点的参与者进行了筛查，但未被充分代表的少数群体的参与情况有所不同。本研究的目的是比较属于边缘化种族和族裔群体的PD参与者的招募策略。
方法
共有998名已确定种族和族裔的参与者从86个临床站点同意参加STEADY-PD III和SURE-PD3。对人口统计学、临床试验特征和招募策略进行了比较。NINDS对STEADY-PD III施加了少数群体招募任务，但对SURE-PD3没有。
结果
同意参加STEADY-PD III的参与者中有10%自我认定为属于边缘化种族和族裔群体，而在SURE-PD3中这一比例为6.5%（差异=3.9%，95%置信区间[CI]0.4%-7.5%，P值=0.034）。筛查后这一差异仍然存在（STEADY-PD III中的患者为10.1%，SURE-PD3中的患者为5.4%，差异=4.7%，95%CI 0.6%-8.8%，P值=0.038）。
讨论
尽管两项试验针对的是相似的参与者，但STEADY-PD III能够同意并招募到更高比例的来自种族和族裔边缘化群体的患者。可能的原因包括实现少数群体招募目标的不同激励措施。
试验注册信息
本研究使用了帕金森病伊拉地平的安全性、耐受性和疗效评估（STEADY-PD III；NCT02168842）和帕金森病尿酸升高研究（SURE-PD3；NCT02642393）的数据。
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