Improving representation of racial and ethnic minorities in pediatric clinical trials - 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.
