Improving representation of racial and ethnic minorities in pediatric clinical trials

提高儿科临床试验中种族和族裔的代表性

• 批准号: 10526170
• 负责人: Mei-Sing Ong
• 金额: $ 26.12万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10526170
• 关键词: Address; Adult; Affect; Asthma; COVID-19; Characteristics; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Cognitive; Complex; Conduct Clinical Trials; Congresses; Data; Databases; Development; Diabetes Mellitus; Disease; Elements; Eligibility Determination; Emotional; Encapsulated; Enrollment; Ensure; Environment; Ethnic Origin; Ethnic group; Excess Mortality; Face; Food; Fostering; Foundations; Future; Genetic; Geography; Goals; Historically Black Colleges and Universities; Institution; International; Intervention; Intervention Studies; Investigation; Journals; Link; Medical; Medical Faculty; Methods; Minority; Minority Enrollment; Minority Groups; Minority Participation; Minority Recruitment; Mission; Monitor; Morbidity - disease rate; Outcome; Participant; Pediatric Research; Pfizer-BioNTech COVID-19 vaccine; Pharmaceutical Preparations; Phase; Play; Policies; Population; Premature Birth; Procedures; Public Health; Race; Randomized; Registries; Research; Research Personnel; Resources; Role; Science; Subgroup; Surveys; Testing; Underserved Population; United States National Institutes of Health; Vaccines; Woman; Work; base; benefit sharing; burden of illness; design; disparity reduction; ethnic diversity; ethnic minority; evidence base; health difference; health disparity; improved; innovation; minority children; minority patient; mortality; novel; operation; parental involvement; racial and ethnic; racial diversity; racial minority; research study; response; socioeconomics; trend; trial design; willingness

PROJECT SUMMARY/ABSTRACT Improving representation of racial and ethnic groups in US clinical trials has been a focus of federal initiatives for nearly 3 decades. Yet, racial and ethnic minority subgroups continue to be underrepresented. Race and ethnicity encapsulate a complex interaction of geographic ancestry (thus clustering of genetic characteristics), living environments, and socioeconomic and cultural factors that may play pivotal roles in the variability of subjects’ response to medical interventions. Inclusion of racially and ethnically diverse participants in clinical trials is therefore crucial to define the reasons for differences in health outcomes, to ensure generalizability and relevance of trial results to all populations, and to allow for equitable access to medical advances. The overall objective of this proposal is to investigate the extent of, and factors associated with, under-representation of racial and ethnic minorities in pediatric clinical trials. The long-term goal is to improve equitable access to pediatric clinical trials. To date, studies on trends in trial participation have primarily focused on adults. The effects of regulatory efforts to enhance minority participation in pediatric clinical trials remain understudied. Clinical trials involving children face unique challenges, including the complexities of parental involvement and the adaptations required in research procedures and settings to accommodate children's physical, cognitive, and emotional development. The lack of available information documenting such disparities compromises our ability to monitor and address this issue. The specific aims of this proposal are: (1) to quantify the representation of minority children in clinical trials conducted in the US (years 2008 to 2021); and (2) to identify facilitators and barriers to minority participation in pediatric trials, with an emphasis on factors that are potentially modifiable by trial investigators and sponsors, including trial design-related and institutional-level factors. The study focuses on clinical trials related to diseases linked to excess morbidity and mortality in minority children in the US, including diabetes, asthma, preterm birth, and COVID-19. While prior research examining trends in trial enrollment typically surveyed only select journals, the proposed work will leverage ClinicalTrials.gov – a national trial registry – as an innovative approach to rapidly assess the state of disparities in pediatric research and to identify potential trial design-related factors contributing to disparities. To enable investigation of institutional factors contributing to disparities in pediatric trials, methods will be developed to link ClinicalTrials.gov with other national databases to characterize the institutions conducting the trials (e.g. institution type, diversity of medical faculty). The proposed study is significant because quantifying disparities in trial enrollment for specific pediatric domains is a first step to identifying gaps and beginning to design of evidence-based solutions. Because the body of clinical trials is constantly evolving, this work will provide not only a snapshot of current pediatric trials, but also a framework and toolkit for surveillance going forward.

项目摘要/摘要 在美国临床试验中，改善种族和族裔的代表性已成为联邦计划的重点 近三十年。然而，种族和少数民族子群体的人数仍然不足。种族和 种族封装了地理祖先的复杂相互作用（因此遗传特征的聚类）， 生活环境以及可能在可变性中起关键作用的社会经济和文化因素 受试者对医疗干预的反应。在临床上包括大致和种族多元化的参与者 因此，试验对于定义健康结果差异的原因至关重要，以确保可推广性和 试验结果与所有人群的相关性，并允许公平访问医疗进步。总体 该提案的目的是调查与代表不足的程度和因素 小儿临床试验中的种族和少数民族。长期目标是提高公平访问 小儿临床试验。迄今为止，关于试验参与趋势的研究主要集中在成年人上。 尚未了解为增强小儿临床试验参与少数群体参与的监管努力的影响。 临床试验涉及儿童面临独特的挑战，包括父母参与的复杂性和 研究程序和设置中所需的适应 和情感发展。缺乏可用的信息文档，这种差异损害了我们 能够监视和解决此问题的能力。该提案的具体目的是：（1）量化 代表少数民族儿童在美国进行的临床试验中（2008年至2021年）； （2）确定 促进者和少数群体参与儿科试验的障碍，重点是 试验研究人员和赞助商可能会修改，包括试验设计相关和机构级别 因素。该研究的重点是与与过量发病率和死亡率有关的疾病有关的临床试验 美国的少数族裔儿童，包括糖尿病，哮喘，早产和19岁。在先前的研究中 检查试验入学率的趋势通常仅对精选期刊进行调查，拟议的工作将利用 ClinicalTrials.gov（国家试用注册中心）作为一种创新的方法来快速评估分布的状态 在小儿研究中，并确定导致差异的潜在试验设计相关因素。启用 研究导致小儿试验差异的制度因素，将开发方法 将ClinicalTrials.GOV与其他国家数据库联系起来，以表征进行试验的机构（例如 机构类型，医学教师的多样性）。拟议的研究很重要，因为量化了差异 特定儿科域的试用招生是识别差距和开始设计的第一步 循证解决方案。由于临床试验的身体不断发展，因此这项工作将不提供 只有当前的小儿试验的快照，还有一个框架和工具包，以进行监视。