An Interview with Professor Florence Bourgeois: on Policy and Regulation of Clinical Trials

Shejla Pollozi,Cindy Xie,Sumedha Sachar,Manraj Gill

doi:10.38105/spr.yv36m9es49

Abstract

For more than 20 years, Dr. Florence Bourgeois, MD, MPH has held multiple positions at the intersection of pediatrics, therapeutics, regulatory science, health informatics and research integrity. A graduate of Yale University, Harvard School of Public Health and Washington University School of Medicine in St. Louis, Dr. Bourgeois’ record transcends academia and medicine. In addition to being a faculty member at Harvard Medical School and the Division of Emergency Medicine and the Computational Health Informatics Program (CHIP) at Boston Children’s Hospital, she is the Director of PedRx, which aims to advance the development and evidence-based use of novel therapeutics for children globally. As the Scientific Director of the Boston Children’s Hospital Biobank, Dr. Bourgeois’ efforts focus on expanding physicians’ capacity to conduct research in pediatric populations. As the Co-Director of the Harvard-MIT Center for Regulatory Science, Dr. Bourgeois also spearheads cross-disciplinary collaborations between academia, biotechnology and pharmaceutical companies, and regulatory agencies. She is the recipient of an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund and has served as an Expert Visitor to the European Medicines Agency to analyze the EU’s pediatric drug legislation. As part of this interview, we examine the relationship between clinical trials and drug development in pediatrics as well as their ethical and social impacts.

Highlights

For more than 20 years, Dr Florence Bourgeois, MD, MPH has held multiple positions at the intersection of pediatrics, therapeutics, regulatory science, health informatics and research integrity
It’s estimated that about 50% of drugs do not have any labeling information around dosing, safety, or efficacy for use in kids, but we still use many of these drugs to treat pediatric patients based on post-approval clinical studies and clinical experience indicating they are safe and effective
We don’t have good therapeutic choices, so when a drug is approved for adults, clinicians take that drug, extrapolate the information from adult populations and through some clinical trial and error, determine whether it’s a safe and effective therapeutic for use in kids

Summary

Introduction

For more than 20 years, Dr Florence Bourgeois, MD, MPH has held multiple positions at the intersection of pediatrics, therapeutics, regulatory science, health informatics and research integrity. Contributions towards improving public health policy is a way to augment the direct impact a physician has at the individual family and patient level with work that can have much broader influence at the population level.

Results

Conclusion