Race/ethnicity matching boosts enrollment of black participants in clinical trials.

Race/ethnicity matching boosts enrollment of black participants in clinical trials.
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种族/族裔匹配提高了临床试验中黑人参与者的入学率。

DOI:
10.1016/j.cct.2022.106936
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发表时间:
2022
影响因子:
2.2
通讯作者:
Arndt,Stephan
Arndt,Stephan
中科院分区:
医学4区
文献类型:
--
作者:
Segre,LisaS;Davila,RebeccaChuffo;Carter,Cheryl;Arndt,Stephan

文献摘要

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背景:对于进行临床试验的研究人员来说,招募具有代表性的种族或少数民族参与者是一项挑战。一种建议的解决方案是种族/民族匹配(即使试验招募者的种族或民族身份与期望参与者的种族或民族身份保持一致),但在实践中,这种想法产生了不同的结果。然而,这种方法似乎天生就很强大,所以我们在二次分析中重新评估了这种策略。方法在两项临床试验的筛选阶段,对黑人受试者的入组情况进行跟踪,两项临床试验由同一PI领导,并在同一环境下进行:中西部一家以白人为主地区的学术医院的新生儿重症监护室。在第一次试验中,招募者是一名来自新生儿重症监护室的白人新生儿护士。在第二次试验中,招聘人员是一名黑人研究护士。在种族/民族匹配的评估中,比较了两项试验中参加筛选阶段的黑人妇女的数量。结果与白人新生儿重症监护室执业护士相比,黑人研究护士在临床试验筛选阶段招募的黑人参与者数量是白人护士的两倍(分别为12.24%和6.1%)。使用Fisher精确检验,黑人参与者入组的6.14个百分点的差异是显著的(p= 0.035)。结论:主要发现是黑人招募者招募的黑人参与者明显多于白人招募者,这表明种族/民族匹配是增加临床研究中少数种族/民族参与的可行策略。
BackgroundEnrollment of a representative sample of racial or ethnic-minority participants can be challenging for researchers conducting clinical trials.One proposed solution is race/ethnicity matching (i.e., aligning the racial or ethnic identity of the trial recruiter with that of the desired participant), but in practice this idea has yielded mixed results. Nevertheless, the approach seems inherently strong, so we reevaluated this strategy in a secondary analysis.MethodsBlack participant enrollment was tracked during the screening phase of two clinical trials led by the same PI and conducted in the same setting: the NICU of a midwestern academic hospital in a predominantly White locale. In the first trial, the recruiter was a White neonatal nurse practitioner from the NICU. In the second trial, the recruiter was a Black research nurse. In this evaluation of race/ethnicity matching, the number of Black women who enrolled into the screening phase of the two trials was compared.ResultsThe Black research nurse enrolled twice as many Black participants into the screening phase of a clinical trial compared to the White NICU neonatal nurse practitioner (12.24% & 6.1%, respectively). The 6.14 percentage-point difference in Black participant enrollment is significant using Fisher's exact test (p= 0.035).ConclusionsThe key finding is that the Black recruiter enrolled a significantly greater number of Black participants than the White recruiter, suggesting that race/ethnicity matching is a viable strategy for increasing racial/ethnic minority participation in clinical studies.