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 改善美国团块中种族和族裔群体的代表性已成为联邦举措的重点 近三十年来，种族和少数民族子群体的代表性不足。 种族封装了地理血统的复杂相互作用（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。 因此，试验对于确定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，并可以公平地访问医疗进展 该提案的目的是调查与不足的程度和因素相关的程度和因素。 小儿临床试验中的种族和少数民族。 小儿临床试验 规律性灭绝对少数群体参与儿科临床试验的影响仍在研究中。 涉及儿童的临床试验将面临独特的挑战，包括父母参与和 在研究程序和设置中需要适应儿童的身体认知能力所需的适应性。 和情感发展。 监视和解决此建议的具体目的是：（1）量化您 代表美国进行的临床儿童（2008年至2021年）； 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，包括试验设计相关的和Intervel级别 该研究的重点是与与过度和荒谬有关的疾病 在美国，涉及糖尿病，哮喘，早产和共同研究的少数族裔儿童 检查试验入学率的趋势通常仅对精选期刊进行调查，拟议的工作杠杆作用 临床试验。gov-国家试验注册中心 - 作为快速评估差异状态的企业企业 在儿科研究中，并确定有助于差异的潜在试验设计相关因素。 研究机构的调查因素导致差异 链接临床Trials.gov与其他国家数据库，以表征该研究所的试验（例如 工厂类型，医学教师的多样性）。 特定儿科域的试用招生是识别差距和开始设计的第一步 基于证据 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。