Clinical Trials with Exclusions Based on Race, Ethnicity, and English Fluency

描述（由申请人提供）：招募不同的人群进行临床试验有助于确保研究结果可推广到更大的人群。本研究的主要目的是识别和描述与少数民族、民族或英语流利程度相关的明确纳入或排除标准的临床试验的特征。虽然最近一些临床试验明确排除非裔美国人的做法引起了倡导组织的注意，但并没有太多研究证明这种排除在多大程度上继续普遍存在。此外，对与此类排除性资格标准相关的试验特征知之甚少。我们假设，在种族和民族更多样化的地区，赞助机构的临床试验更有可能具有与种族、民族或英语流利相关的资格标准。我们建议在本项目中使用ClinicalTrials.gov数据库中的数据。我们将把ClinicalTrials.gov的数据与美国人口普查和美国社区调查的数据联系起来，以获得赞助这些试验的机构周围地区的信息。我们也会记录排他性语言的理由。我们的初步研究结果表明，研究者希望增加其试验的内部效度是排除少数民族的主要动机。事实上，在试图确保临床试验的内部和外部有效性方面存在固有的权衡。内部效度指的是一项研究正确确定干预措施是否有效的能力，而外部效度指的是一项研究的发现在更广泛的人群中被复制的能力。增加试验的外部效度会增加效应估计量的异质性，从而降低试验的内部效度。这个R03项目将记录美国临床试验中种族、民族和英语语言被排除在外的普遍情况。本研究还将提供对可能存在排他性语言的研究类型的见解。这些信息可用于识别具有高排他性语言风险的试验类型。此外，未来的工作可以调查与排除资格标准相关的一些变量，以及在本项目过程中确定的变量是否可以用于开发可以减少明确排除标准的干预措施。

DESCRIPTION (provided by applicant): Recruiting diverse populations to clinical trials helps ensure that study results are generalizable to the population at large. The primary goal of this study is to identify and describe characteristics of clinical trials that have explicit inclusion o exclusion criteria related to minority race, ethnicity, or English fluency. While explicit exclusio of African Americans from some recent clinical trials has received attention from advocacy organizations, there has not been much research documenting the degree to which such exclusions continue to be widespread. Also, little is known about the characteristics of trials tha are associated with such exclusionary eligibility criteria. We hypothesize that clinical trials wit sponsoring institutions located in more racially and ethnically diverse areas are more likely to have racial, ethnic, or English fluency-related eligibility criteria. We propose using data from th ClinicalTrials.gov database for this project. We will link the ClinicalTrials.gov data to United States Census and American Community Survey data to obtain information on the areas surrounding institutions that sponsor these trials. We will also record justifications given for exclusionary language. Our preliminary findings suggest that investigator desires to increase the internal validity of their trials is a primary motivator for excluding minorities. Indeed, there isan inherent tradeoff in trying to ensure both the internal and external validity of clinical trials. Te internal validity refers to the ability of a study to correctly determine whether an intervention i efficacious, while external validity refers to the ability of a study's findings to be replicated i a more general population. Increasing a trial's external validity can increase heterogeneity in effect estimators which reduces the internal validity of the trial. This R03 project will document the prevalence of racial, ethnic, and English language exclusions in clinical trials accruing in th United States. This study will also provide insight into the types of studies that are likely to hae exclusionary language. Such information can be useful in identifying the types of trials at high risk of having exclusionary language. Also, future work could investigate whether some of the variables associated with exclusionary eligibility criteria and identified over the course of this project might be used to develop interventions that could reduce explicit exclusionary criteria.