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Principal Investigator: Elliott M Weiss
Organization: SEATTLE CHILDREN'S HOSPITAL
Fiscal Year: 2024
Award: $160,283
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <Address><Advisory Committees><Agreement><Area><Black><Black race><Career Development Awards><Career Development Awards and Programs><Career Development Programs K-Series><Clinical><Clinical Research><Clinical Study><Clinical Trials><Complex><Data><ECSF><Economic Income><Economical Income><Education><Educational aspects><Eligibility><Eligibility Determination><Enrollment><Environment><Epoetin><Erythropoietin><Ethics><Familiarity><Family><Family Process><Foundations><Future><Goals><Grant><Health><Income><Infant><Informed Consent><Intervention><Intervention Strategies><Interview><Investigators><K-Awards><K-Series Research Career Programs><K23 Award><K23 Mechanism><K23 Program><Knowledge><Learning><Long term disability><Low income><Medicaid><Mentored Patient-Oriented Research Career Development Award><Mentored Patient-Oriented Research Career Development Award (K23)><Mentors><Mentorship><Methodology><Methods><Morbidity><Morbidity - disease rate><Neonatal><Neuroprotectants><Neuroprotective Agents><Neuroprotective Drugs><Operations Research><Outcome><Parents><Participant><Patients><Population><Population Heterogeneity><Procedures><Process><Protocol Screening><Publications><Randomized, Controlled Trials><Reporting><Research><Research Career Program><Research Ethics><Research Personnel><Researchers><Sampling><Scientific Publication><Shapes><Site><Structure><Survey Instrument><Surveys><Task Forces><Techniques><Testing><Training><Underrepresented Groups><Underrepresented Populations><Work><acceptability and feasibility><advisory team><career development><clinical trial enrollment><cohort><cost><data integration><design><designing><determine efficacy><develop therapy><disparity in health><diverse populations><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><enroll><erythrocyte colony stimulating factor><ethical><ethnic minority><evaluate efficacy><evidence base><examine efficacy><experience><extreme prematurity><extremely premature infant><extremely preterm><extremely preterm infant><feasibility testing><health disparity><health literacy><hematopoietin><heterogeneous population><high risk><hypoxic ischemic encephalopathy><improved><improved outcome><incomes><intervention development><intervention mapping><interventional strategy><mortality><multidisciplinary><neonatal HIE><neonatal hypoxia-ischemia><neonatal hypoxic-ischemic brain injury><neonatal hypoxic-ischemic encephalopathy><parent><pilot test><population diversity><racial minority><randomized control trial><recruit><skills><sound><theories><therapy development><treatment development><under representation of groups><under represented groups><under represented people><under represented populations><underrepresentation of groups><underrepresented people><very premature><very preterm><work group><working group>