Improving Diversity in Neonatal Clinical Trial Enrollment

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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.