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研究人员对临床试验中少数族裔参与的看法、障碍和建议。

Research Professionals' Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials.

机构信息

Department of Emergency Medicine Research, Lehigh Valley Health Network, Allentown, PA, USA.

Department of Emergency Medicine Research, Lehigh Valley Health Network, 2545 Schoenersville Road, 4th Floor, Bethlehem, 18017, USA.

出版信息

J Racial Ethn Health Disparities. 2017 Dec;4(6):1166-1174. doi: 10.1007/s40615-016-0322-0. Epub 2016 Dec 21.

DOI:10.1007/s40615-016-0322-0
PMID:28004355
Abstract

OBJECTIVE

This study aims to investigate research professionals' perspectives regarding minority participation in clinical trials.

METHODS

A web-based survey of research professionals at US institutions receiving NIH and/or AHRQ funding to conduct clinical research in 2013. Descriptive statistics, mean, standard deviation (SD), and the Wilcoxon rank-sum test were utilized for analysis.

RESULTS

Distributed were 13,041 surveys with 967 (7.4%) responses. Overall and race-stratified analyses included 633 and 521 surveys, respectively. A majority agreed that patients' race (mean, 3.4; SD = 1.0) and primary language (mean, 4.0; SD = 0.9) have an effect on enrollment. They had more success in enrolling those whose primary language was the same as their own (mean, 3.8; SD = 1.0), and that a language barrier and time spent arranging for interpreters had prevented them from offering a study to potential candidates (mean, 3.2; SD = 1.2). Non-Caucasian respondents were more likely to agree that "fear of unknown side effects" was a deterrent for minorities (p < 0.01), "minorities are more likely to be unavailable for follow-up phone calls" (p = 0.07), and "the unavailability of translated material discourages non-English speakers from participation" (p = 0.08). They also were more likely to be neutral or agree with being discouraged from enrolling minorities because of the possibility of their withdrawal or being less likely to be available for phone follow-ups and follow-up visits (all p < 0.01).

CONCLUSION

Despite a few subtle racial differences in research professionals' perspectives, a majority expressed no hesitation in enrolling minorities. Patients' race and primary language appeared to influence enrollment. A language barrier appeared to be the strongest barrier for research professionals.

摘要

目的

本研究旨在探讨研究专业人员对少数族裔参与临床试验的看法。

方法

2013 年,对美国机构的研究专业人员进行了一项基于网络的调查,这些机构接受 NIH 和/或 AHRQ 的资助,以进行临床研究。采用描述性统计、平均值、标准差(SD)和 Wilcoxon 秩和检验进行分析。

结果

共发放了 13041 份调查问卷,其中 967 份(7.4%)做出了回应。总体分析和种族分层分析分别包括 633 份和 521 份调查。大多数人认为患者的种族(平均值 3.4,SD=1.0)和主要语言(平均值 4.0,SD=0.9)会影响入组。他们在招募与自己语言相同的人时成功率更高(平均值 3.8,SD=1.0),而且语言障碍和安排翻译人员的时间阻碍了他们向潜在候选人提供研究(平均值 3.2,SD=1.2)。非白种人受访者更有可能同意“对未知副作用的恐惧”是少数族裔的一个障碍(p<0.01),“少数族裔更有可能无法接听随访电话”(p=0.07),“缺乏翻译材料阻碍了非英语使用者参与”(p=0.08)。他们也更有可能对因少数族裔可能退出或不太可能接听电话随访和随访而劝阻招募他们持中立或同意态度(所有 p<0.01)。

结论

尽管研究专业人员的观点存在一些细微的种族差异,但大多数人表示毫不犹豫地招募少数族裔。患者的种族和主要语言似乎影响了入组。语言障碍似乎是研究人员面临的最大障碍。

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