OVERVIEW: The Regulatory Science Research Team is a student-initiated, student driven organization housed in the D.K. Kim International Center for Regulatory Science. The Research Team is funded by SC CTSI, the USC Undergraduate Research Associates Program, and individual fellowships. Research in regulatory science continues to foster innovation in regulatory policies and practice, shapes the development and improvement of regulations and guidance regarding drugs, biologics, medical devices, combination products, and dietary supplements at local, federal, and international levels.
GOALS: Our mission is to provide cross-training for talented undergraduate and graduate students to drive the ongoing initiative in promoting efficient, safe, compliant, and high-quality clinical and nonclinical studies that aid the commercialization of regulated products.
CURRENT STATUS: Current research topics include: “Review of Government-Sponsored Studies and FDA Guidance for COVID-19 Diagnostic Testing, Treatments, and Vaccines”; “Quality, Safety, and Efficacy Issues Surrounding Dietary Supplements”; “Templates and Natural Language Processing to Support Clinical Trial Language Accessibility and Plain Language Clinical Trial Summary Development”; “Barriers to Diabetes Technologies in Low-Income Patients”; “Diversity Inclusion in Clinical Trials for Chronic Diseases Conducted in Los Angeles County”; “The Impact of COVID-19 on the US Pharmaceutical Clinical Trial Landscape: A Cross-Sectional Analysis of ClinicalTrials.gov Data”; “Representation of Children and Adolescents in Clinical Trials for Anxiety and Depression Treatments”, and “Pediatric Inclusion in Clinical Trials”. On the last topic, we found that 54% of 135 studies opened to adults and pediatrics approved by FDA between 2016 and 2018 had less than 1% pediatric representation. There is a lack of pediatric representation in clinical trials involving both adult and pediatric populations, and a comprehensive pediatric representation in clinical trials is necessary to provide further safety, efficacy, and dosage information for pediatric labeling.