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

基于种族、民族和英语流利程度进行排除的临床试验

• 批准号: 8608501
• 负责人: Brian L Egleston
• 金额: $ 8.66万
• 依托单位: RESEARCH INST OF FOX CHASE CAN CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8608501
• 关键词: African American; American; Area; Attention; Attention deficit hyperactivity disorder; Cataloging; Catalogs; Caucasians; Caucasoid Race; Censuses; Characteristics; Clinical; Clinical Trials; Clinical Trials Database; Clinical trial protocol document; Collection; Community Surveys; Couples; Data; Data Base Management; Databases; Eligibility Determination; English Language; Enrollment; Ensure; Ethnic Origin; European; Exclusion; Exclusion Criteria; Family; Fright; Future; Gays; General Population; Genetic; Goals; Health; Heterogeneity; Home environment; Human; Industry; Institution; Intervention; Journals; Language; Lesbian; Lesbian Gay Bisexual Transgender; Letters; Link; Malignant neoplasm of prostate; Medical center; Medicine; Methods; Minority; Minority Groups; Neighborhoods; New England; Outcome; Participant; Patients; Phase III Clinical Trials; Population; Population Heterogeneity; Prevalence; Protocols documentation; Publishing; Race; Recruitment Activity; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Running; Services; Sex Orientation; Site; Subgroup; United States; Wit; Work; advocacy organizations; base; caucasian American; cost; design; high risk; inclusion criteria; insight; malignant breast neoplasm; novel; public health relevance; racial and ethnic; skills; African American; American; Area; Attention; Attention deficit hyperactivity disorder; Cataloging; Catalogs; Caucasians; Caucasoid Race; Censuses; Characteristics; Clinical; Clinical Trials; Clinical Trials Database; Clinical trial protocol document; Collection; Community Surveys; Couples; Data; Data Base Management; Databases; Eligibility Determination; English Language; Enrollment; Ensure; Ethnic Origin; European; Exclusion; Exclusion Criteria; Family; Fright; Future; Gays; General Population; Genetic; Goals; Health; Heterogeneity; Home environment; Human; Industry; Institution; Intervention; Journals; Language; Lesbian; Lesbian Gay Bisexual Transgender; Letters; Link; Malignant neoplasm of prostate; Medical center; Medicine; Methods; Minority; Minority Groups; Neighborhoods; New England; Outcome; Participant; Patients; Phase III Clinical Trials; Population; Population Heterogeneity; Prevalence; Protocols documentation; Publishing; Race; Recruitment Activity; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Running; Services; Sex Orientation; Site; Subgroup; United States; Wit; Work; advocacy organizations; base; caucasian American; cost; design; high risk; inclusion criteria; insight; malignant breast neoplasm; novel; public health relevance; racial and ethnic; skills

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.

描述（由申请人提供）：招募各种人群参加临床试验，有助于确保研究结果可推广到整个人群。这项研究的主要目的是识别和描述具有明确包含的临床试验的特征o与少数族裔，种族或英语流利性有关的排除标准。尽管在最近的一些临床试验中明确的非洲裔美国人的明确排他性受到了倡导组织的关注，但并没有太多的研究记录了这种排除次数继续被广泛普及的程度。同样，关于试验的特征与此类排除资格标准有关。我们假设，临床试验的WIT赞助机构在种族和种族上多样化的地区更有可能具有种族，种族或英国流利性相关的资格标准。我们建议使用该项目的数据库中的数据。GOV数据库。我们将链接临床。我们还将记录有关排除语言的理由。我们的初步发现表明，研究人员希望提高试验的内部有效性是排除少数民族的主要动机。确实，伊斯（Isan）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。 TE内部有效性是指研究正确确定干预措施是否有效的能力，而外部有效性是指研究结果复制的能力I更普遍。提高试验的外部有效性可以提高异质性，从而有效估计量，从而降低了试验的内部有效性。该R03项目将记录美国在美国临床试验中种族，种族和英语排除的普遍性。这项研究还将洞悉可能具有排他性语言的研究类型。此类信息对于确定具有排除语言的高风险的试验类型可能很有用。同样，未来的工作可以调查是否可以使用与排除资格标准相关的一些变量并在该项目的整个过程中确定，以开发可以减少明确排除标准的干预措施。