IMPACT OF COVID-19 ON CLINICAL RESEARCH AND INCLUSION OF DIVERSE POPULATIONS
IMPACT OF COVID-19 ON CLINICAL RESEARCH AND INCLUSION OF DIVERSE POPULATIONS
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DOI：
10.18865/ed.30.3.429
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发表时间：
2020-06-01
影响因子：
3.2
通讯作者：
Voeks, Jenifer H.
中科院分区：
文献类型：
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作者：
Lackland, Daniel T.;Sims-Robinson, Catrina;Voeks, Jenifer H.
长期以来，随机临床试验(RCT)一直被认为是开发临床治疗和疫苗证据的“黄金标准”；然而，这些发现的成功实施和翻译取决于外部有效性。由于缺乏非洲裔美国人等高危群体的参与，缺乏长期公认的不成比例代表制，有损于循证医学研究结果的普遍性。阻碍参与随机对照试验的明显因素包括不信任、机会、招聘战略、对研究的看法以及社会经济因素。虽然已经实施了战略，以提高随机对照试验的外部有效性，使所有人群更多地参与随机对照试验，但2019年冠状病毒病(新冠肺炎)大流行可能会加剧随机对照试验参与方面的差距，推迟适用和可推广的治疗开发和疫苗干预的潜在影响。因此，必须将不同的人口纳入这类战略和区域协调小组。这一观点旨在引导人们注意这一大流行病的额外危害，并重新关注尚未解决的不同人群在开展随机对照试验时缺乏纳入的问题。
The randomized clinical trial (RCT) has long been recognized as the 'gold standard' for developing evidence for clinical treatments and vaccines; however, the successful implementation and translation of these findings is predicated upon external validity. The generalization of RCT findings are jeopardized by the lack of participation of at-risk groups such as African Americans, with long-recognized disproportional representation. Distinct factors that deter participation in RCTs include distrust, access, recruitment strategies, perceptions of research, and socioeconomic factors. While strategies have been implemented to improve external validity with greater participation among all segments of the population in RC:Ts, the coronavirus disease 2019 (COVID-19) pandemic may exacerbate disparities in RCT participation with the potential impact of delaying treatment development and vaccine interventions that are applicable and generalizable. Thus, it is essential to include diverse populations in such strategies and RCTs. This Perspective aims to direct attention to the additional harm from the pandemic as well as a refocus on the unresolved lack of inclusion of diverse populations in conducting RCTs.