Improving Diversity in Neonatal Clinical Trial Enrollment

项目摘要/摘要 新生儿临床试验难以纳入不同人群的婴儿。有种族背景的婴儿的父母 或少数民族，报告收入较低，或教育程度较低的人较少接触， 更有可能拒绝入学，也更有可能退出新生儿研究。代表人数不足 这些人口导致了一个可能不能推广的证据基础。这一点至关重要，因为这些 婴儿因许多常见的新生儿问题和相关的发病率而出现较差结局的风险更高， 死亡率、成本和长期残疾。因此，在新生儿临床试验中代表性不足加剧了 现有的健康差距。从实践和道德的角度来看，迫切需要解决这一问题。 有问题。拟议的K23奖项将支持埃利奥特·M·韦斯博士的职业发展 在改善新生儿临床试验招募程序和招募多样性的战略方面的专业知识， 重点放在代表性不足的人群上。该项目将促进三个具体领域的培训：1) 健康差异、研究参与者多样性和利益相关者参与；2)干预发展 和测试；3)研究操作和临床试验。Weiss博士的职业发展将得到以下支持 一支高度熟练的指导团队，具备定性方法、利益相关者参与以及 干预开发和测试。咨询团队将在健康差距方面提供进一步的支持， 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。这次培训 而导师将为拟议的研究提供信息。这项研究将由干预地图指导，一种 整合理论和实证结果以开发健康干预措施的严格技术，以便 实现创建修改后的招聘方法以增加招生人数的目标，更多 可概括的结果，以及改进的结果。目标1是描述代表不足的父母是如何 人口决定是否让他们的婴儿参加新生儿研究。目标2是创建修改后的招聘 旨在改进家庭招聘程序并增加未成年儿童的参与的办法 新生儿研究中的代表性人群。目标3是试行测试实施修改后的 新生儿临床试验中的招募方法。韦斯博士从事这项工作的环境 项目是无与伦比的，可以获得指导、课程、临床和办公空间，以及研究和拨款 管理和行政支持。在职业发展奖结束时，韦斯博士将 拥有培训、试点数据和出版物，使他能够成功提交并进行R01级别的考试 项目测试假设，道德上合理的修改后的招聘方法将提高招生人数 提高新生儿临床试验的多样性和可推广性。

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.