Improving Diversity in Neonatal Clinical Trial Enrollment

提高新生儿临床试验入组的多样性

• 批准号: 10371172
• 负责人: Elliott M Weiss
• 金额: $ 16.12万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-12 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10371172
• 关键词: Address; Advisory Committees; Area; Black race; Clinical; Clinical Research; Clinical Trials; Complex; Data; Enrollment; Environment; Erythropoietin; Ethics; Familiarity; Family; Family Process; Foundations; Future; Goals; Health; Health Disparities Research; Income; Infant; Informed Consent; Intervention; Interview; K-Series Research Career Programs; Knowledge; Lead; Learning; Low income; Medicaid; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methodology; Methods; Morbidity - disease rate; Neonatal; Neuroprotective Agents; Operations Research; Outcome; Parents; Participant; Partner in relationship; Patients; Population; Population Heterogeneity; Procedures; Process; Publications; Randomized Controlled Trials; Reporting; Research; Research Ethics; Research Personnel; Research Project Grants; Sampling; Shapes; Site; Structure; Surveys; Techniques; Testing; Training; Underrepresented Populations; Work; acceptability and feasibility; career development; clinical trial enrollment; cohort; cost; design; disability; ethnic minority; evidence base; experience; feasibility testing; health disparity; health literacy; high risk; improved; improved outcome; intervention mapping; mortality; multidisciplinary; neonatal hypoxic-ischemic brain injury; pilot test; racial minority; recruit; sound; theories; therapy development; working group

PROJECT SUMMARY/ABSTRACT Neonatal clinical trials have difficulty including diverse populations of infants. Parents of infants who are racial or ethnic minorities, report lower income, or have lower educational attainment are less often approached, more likely to decline enrollment, and more likely to withdraw from neonatal research. Under-representation of these populations results in an evidence base that may not be generalizable. This is crucial because these infants are at higher risk for worse outcomes for many common neonatal problems and associated morbidity, mortality, cost, and long-term disabilities. Under-representation in neonatal clinical trials thus exacerbates existing health disparities. From a practical and ethical perspective, there is a critical need to address this problem. The proposed K23 award will support the career development of Dr. Elliott M Weiss as he develops expertise in strategies to improve recruitment processes and enrollment diversity for neonatal clinical trials, with a focus on under-represented populations. This project will facilitate training in three specific areas: 1) health disparities, research participant diversity, and stakeholder engagement; 2) intervention development and testing; and 3) research operations and clinical trials. Dr. Weiss’s career development will be supported by a highly skilled mentoring team with expertise in qualitative methodologies, stakeholder engagement, and intervention development and testing. The advisory team will provide further support in health disparities, research participant diversity, research ethics and informed consent, and neonatal clinical trials. This training and mentorship will inform the proposed research. The research will be guided by Intervention Mapping, a rigorous technique for integrating theory and empirical findings to develop health interventions, in order to achieve the goal of creating a modified recruitment approach that can lead to increased enrollment, more generalizable results, and improved outcomes. Aim 1 is to describe how parents of under-represented populations decide whether to enroll their infant in neonatal research. Aim 2 is to create a modified recruitment approach designed to improve the recruitment process for families and to increase participation of under- represented populations in neonatal research. Aim 3 is to pilot test the feasibility of implementing a modified recruitment approach within a neonatal clinical trial. The environment in which Dr. Weiss will undertake this project is unparalleled, with access to mentoring, coursework, clinical and office space, and research, grants management, and administrative support. At the conclusion of this career development award, Dr. Weiss will have the training, pilot data, and publications to allow him to successfully submit and undertake an R01-level project testing the hypothesis that an ethically sound modified recruitment approach will improve the enrollment process for all families and increase diversity and improve generalizability of neonatal clinical trials.

项目总结/摘要 新生儿临床试验难以包括不同的婴儿群体。有种族歧视的婴儿的父母 或少数族裔，报告收入较低，或教育程度较低， 更有可能减少入学人数，更有可能退出新生儿研究。任职人数不足 这些人群产生的证据基础可能无法推广。这一点至关重要，因为 对于许多常见的新生儿问题和相关的发病率， 死亡率、成本和长期残疾。因此，新生儿临床试验中的代表性不足加剧了 现有的健康差距。从实际和道德的角度来看，迫切需要解决这个问题 问题.拟议的K23奖将支持埃利奥特M韦斯博士的职业发展，因为他开发 在改善新生儿临床试验招募流程和招募多样性的策略方面拥有专业知识， 重点关注代表性不足的人群。该项目将促进三个具体领域的培训： 健康差异、研究参与者多样性和利益相关者参与; 2）干预措施的制定 和测试;和3）研究操作和临床试验。韦斯博士的职业发展将得到以下人员的支持 一个高技能的指导团队，在定性方法、利益相关者参与方面具有专业知识， 干预开发和测试。咨询小组将在健康差距方面提供进一步的支助， 研究参与者多样性、研究伦理和知情同意以及新生儿临床试验。本次培训 和指导将为拟议的研究提供信息。这项研究将由干预地图， 采用严格的技术，将理论和实证研究结果结合起来，制定健康干预措施， 实现创建一个修改的招聘方法，可以导致增加招生的目标，更多 可推广的结果和改进的结果。目标1是描述代表性不足的父母如何 人们决定是否让他们的婴儿参加新生儿研究。目标2是创建一个修改的招聘 旨在改善家庭招聘程序和增加未成年人参与的办法， 代表新生儿研究中的人群。目标3是试点测试实施经修改的 新生儿临床试验中的招募方法。韦斯博士将承担这项工作的环境 该项目是无与伦比的，可以获得指导，课程，临床和办公空间，以及研究，赠款 管理和行政支助。在本次职业发展奖结束时，韦斯博士将 有培训、试验数据和出版物，使他能够成功提交并进行R 01级 项目测试的假设，一个道德健全的修改招聘方法将提高入学率 为所有家庭提供临床试验程序，增加多样性，提高新生儿临床试验的普遍性。