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.

项目总结/摘要 提高美国临床试验中种族和民族群体的代表性一直是联邦倡议的重点 近三十年了然而，少数种族和族裔群体的代表性仍然不足。种族和 种族包含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，社会经济和文化因素，可能发挥关键作用的变化， 受试者对医疗干预的反应。在临床试验中纳入不同种族和族裔的参与者 因此，试验对于确定健康结果差异的原因，确保普遍性和 试验结果与所有人群的相关性，并允许公平获得医学进步。整体 这项建议的目的是调查妇女任职人数不足的程度和相关因素， 种族和少数民族的儿科临床试验。长期目标是改善公平获得 儿科临床试验迄今为止，关于试验参与趋势的研究主要集中在成人身上。的 加强少数人参与儿科临床试验的监管努力的效果仍然没有得到充分研究。 涉及儿童的临床试验面临着独特的挑战，包括父母参与的复杂性， 在研究程序和设置中需要进行调整，以适应儿童的身体，认知， 和情感发展。缺乏记录这种差异的可用信息， 有能力监督和解决这个问题。该建议的具体目标是：（1）量化 在美国进行的临床试验中少数民族儿童的代表性（2008年至2021年）;以及（2）确定 促进者和障碍，少数参与儿科试验，重点是因素， 可能由试验研究者和申办者修改，包括试验设计相关和机构水平 因素这项研究的重点是与过度发病率和死亡率相关的疾病的临床试验， 美国的少数民族儿童，包括糖尿病、哮喘、早产和COVID-19。虽然先前的研究 研究通常只调查选定期刊的试验招募趋势，拟议的工作将利用 ClinicalTrials.gov国家试验登记处-作为快速评估差异状况的创新方法 在儿科研究中，并确定潜在的试验设计相关因素造成的差异。使 调查导致儿科试验差异的机构因素，将开发方法， 将ClinicalTrials.gov与其他国家数据库连接起来，以说明进行试验的机构的特点（例如， 机构类型，医学系的多样性）。这项拟议的研究意义重大，因为量化的差距， 特定儿科领域的试验招募是确定差距并开始设计 基于证据的解决方案。由于临床试验的主体是不断发展的，这项工作将提供不 这不仅是当前儿科试验的一个快照，也是一个框架和工具包，用于未来的监测。