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

描述（由申请人提供）：招募不同人群参加临床试验有助于确保研究结果可推广到广大人群。本研究的主要目的是识别和描述明确纳入或排除与少数民族、种族或英语流利性相关的标准的临床试验的特征。虽然最近的一些临床试验中明确排除非裔美国人已经引起了倡导组织的关注，但没有太多的研究记录这种排除继续广泛存在的程度。此外，很少有人知道的特点，试验，这是与这种排除性的资格标准。我们假设，位于种族和民族更加多样化的地区的申办机构的临床试验更有可能具有种族，民族或英语流利性相关的资格标准。我们建议在这个项目中使用来自ClinicalTrials.gov数据库的数据。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链接起来，以获得有关赞助这些试验的机构周围地区的信息。我们还将记录排除性语言的理由。我们的初步研究结果表明，研究者希望增加他们的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时存在固有的权衡。内部效度是指研究正确确定干预措施是否有效的能力，而外部效度是指研究结果在更一般人群中复制的能力。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。本R03项目将记录美国临床试验中种族、民族和英语排除的流行率。这项研究也将提供对可能有排除性语言的研究类型的深入了解。这类信息可有助于确定哪些类型的审判极有可能使用排斥性语言。此外，未来的工作可以调查是否可以使用与排除性资格标准相关并在本项目过程中确定的一些变量来制定可以减少明确的排除性标准的干预措施。

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.