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
基本信息
- 批准号:10526170
- 负责人:
- 金额:$ 26.12万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdultAffectAsthmaCOVID-19CharacteristicsChildChildhoodClinicalClinical ResearchClinical TrialsCognitiveComplexConduct Clinical TrialsCongressesDataDatabasesDevelopmentDiabetes MellitusDiseaseElementsEligibility DeterminationEmotionalEncapsulatedEnrollmentEnsureEnvironmentEthnic OriginEthnic groupExcess MortalityFaceFoodFosteringFoundationsFutureGeneticGeographyGoalsHistorically Black Colleges and UniversitiesInstitutionInternationalInterventionIntervention StudiesInvestigationJournalsLinkMedicalMedical FacultyMethodsMinorityMinority EnrollmentMinority GroupsMinority ParticipationMinority RecruitmentMissionMonitorMorbidity - disease rateOutcomeParticipantPediatric ResearchPfizer-BioNTech COVID-19 vaccinePharmaceutical PreparationsPhasePlayPoliciesPopulationPremature BirthProceduresPublic HealthRaceRandomizedRegistriesResearchResearch PersonnelResourcesRoleScienceSubgroupSurveysTestingUnderserved PopulationUnited States National Institutes of HealthVaccinesWomanWorkbasebenefit sharingburden of illnessdesigndisparity reductionethnic diversityethnic minorityevidence basehealth differencehealth disparityimprovedinnovationminority childrenminority patientmortalitynoveloperationparental involvementracial and ethnicracial diversityracial minorityresearch studyresponsesocioeconomicstrendtrial designwillingness
项目摘要
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
提高种族和民族在美国临床试验中的代表性一直是联邦倡议的重点
已经近30年了。然而,种族和少数民族亚群的代表性仍然偏低。种族和
种族概括了地理祖先的复杂相互作用(因此遗传特征的聚集性),
生活环境,以及社会经济和文化因素,这些因素可能在
受试者对医疗干预的反应。将不同种族和民族的参与者纳入临床
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,并允许公平地获得医学进步。整体而言
这项提案的目的是调查代表不足的程度和相关因素
种族和少数民族在儿科临床试验中的作用。长期目标是改善公平获得
儿科临床试验。到目前为止,关于试验参与趋势的研究主要集中在成年人身上。这个
加强少数人参与儿科临床试验的监管努力的效果仍未得到充分研究。
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和
在研究程序和环境中所需的适应,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损害了我们的
有能力监控和解决此问题。这项建议的具体目标是:(1)量化
少数族裔儿童在美国进行的临床试验中的代表性(2008至2021年);以及(2)确定
促进者和少数群体参与儿科试验的障碍,重点是下列因素
可能由试验调查员和赞助商修改,包括与试验设计有关的和机构一级的
各种因素。这项研究的重点是与过度发病率和死亡率有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、早产和新冠肺炎。虽然之前的研究
审查试验登记的趋势,通常只调查选定的期刊,拟议的工作将利用
ClinicalTrials.gov--一家全国性的试验注册机构--作为一种快速评估差异状况的创新方法
在儿科研究中,并找出造成差异的潜在试验设计相关因素。要启用
调查造成儿科试验差异的体制因素,将开发方法以
将ClinicalTrials.gov与其他国家数据库链接,以确定进行试验的机构的特征(例如
机构类型、医务人员的多样性)。这项拟议的研究意义重大,因为量化
对特定儿科领域的试验登记是确定差距并开始设计
循证解决方案。由于临床试验的主体在不断演变,这项工作将不会提供
不仅是当前儿科试验的快照,而且还是未来监测的框架和工具包。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Mei-Sing Ong其他文献
Mei-Sing Ong的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Mei-Sing Ong', 18)}}的其他基金
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:
10706490 - 财政年份:2022
- 资助金额:
$ 26.12万 - 项目类别:
相似海外基金
Co-designing a lifestyle, stop-vaping intervention for ex-smoking, adult vapers (CLOVER study)
为戒烟的成年电子烟使用者共同设计生活方式、戒烟干预措施(CLOVER 研究)
- 批准号:
MR/Z503605/1 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Research Grant
Early Life Antecedents Predicting Adult Daily Affective Reactivity to Stress
早期生活经历预测成人对压力的日常情感反应
- 批准号:
2336167 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Standard Grant
RAPID: Affective Mechanisms of Adjustment in Diverse Emerging Adult Student Communities Before, During, and Beyond the COVID-19 Pandemic
RAPID:COVID-19 大流行之前、期间和之后不同新兴成人学生社区的情感调整机制
- 批准号:
2402691 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Standard Grant
Elucidation of Adult Newt Cells Regulating the ZRS enhancer during Limb Regeneration
阐明成体蝾螈细胞在肢体再生过程中调节 ZRS 增强子
- 批准号:
24K12150 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Migrant Youth and the Sociolegal Construction of Child and Adult Categories
流动青年与儿童和成人类别的社会法律建构
- 批准号:
2341428 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Standard Grant
Understanding how platelets mediate new neuron formation in the adult brain
了解血小板如何介导成人大脑中新神经元的形成
- 批准号:
DE240100561 - 财政年份:2024
- 资助金额:
$ 26.12万 - 项目类别:
Discovery Early Career Researcher Award
Laboratory testing and development of a new adult ankle splint
新型成人踝关节夹板的实验室测试和开发
- 批准号:
10065645 - 财政年份:2023
- 资助金额:
$ 26.12万 - 项目类别:
Collaborative R&D
Usefulness of a question prompt sheet for onco-fertility in adolescent and young adult patients under 25 years old.
问题提示表对于 25 岁以下青少年和年轻成年患者的肿瘤生育力的有用性。
- 批准号:
23K09542 - 财政年份:2023
- 资助金额:
$ 26.12万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Identification of new specific molecules associated with right ventricular dysfunction in adult patients with congenital heart disease
鉴定与成年先天性心脏病患者右心室功能障碍相关的新特异性分子
- 批准号:
23K07552 - 财政年份:2023
- 资助金额:
$ 26.12万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Issue identifications and model developments in transitional care for patients with adult congenital heart disease.
成人先天性心脏病患者过渡护理的问题识别和模型开发。
- 批准号:
23K07559 - 财政年份:2023
- 资助金额:
$ 26.12万 - 项目类别:
Grant-in-Aid for Scientific Research (C)