ABOUT THE RESEARCHER

OVERVIEW

Dr. Bourgeois’ research is focused on applying a combination of clinical epidemiology and big data analytics to evaluate the regulation and use of medications in children and assess the integrity and availability of clinical data to support evidence-based pediatric care. She has extensive experience in the analysis of national healthcare datasets and clinical trial registries, and has leveraged these to examine medication utilization patterns, the design and conduct of clinical trials in children, and the adequacy of pre-market pediatric safety and efficacy assessments in pediatric patient populations. Dr. Bourgeois is the Director of the Pediatric Therapeutics and Regulatory Science Initiative at Boston Children’s Hospital and served as an Expert Visitor at the European Medicines Agency, where she led a project analyzing the implementation of the EUs Pediatric Regulation in order to assess approaches to increase pediatric drug research and product labeling.

As the Scientific Director of the Boston Children’s Hospital Biobank, Dr. Bourgeois is developing novel approaches and informatics-based tools to integrate clinical data with biospecimens and augment our capacity to conduct research in pediatric populations, especially those with rare diseases. Her clinical training and experience are in pediatrics and pediatric emergency medicine.

BACKGROUND

Florence Bourgeois is an Associate Professor of Pediatrics at Harvard Medical School and a faculty member in the Division of Emergency Medicine and the Computational Health Informatics Program (CHIP) at Boston Children’s Hospital. Dr. Bourgeois is a graduate of Yale University and Washington University School of Medicine in St. Louis. She completed her residency training in pediatrics and fellowship in pediatric emergency medicine at Boston Children’s Hospital. She was a NRSA research fellow and obtained a Master in Public Health in clinical effectiveness at the Harvard School of Public Health.

PUBLICATIONS

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  1. International Comparisons of Harmonized Laboratory Value Trajectories to Predict Severe COVID-19: Leveraging the 4CE Collaborative Across 342 Hospitals and 6 Countries: A Retrospective Cohort Study. medRxiv. 2021 Feb 05. View abstract
  2. Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE. Sci Rep. 2021 01 21; 11(1):2051. View abstract
  3. Association of Selective Serotonin Reuptake Inhibitors With the Risk of Type 2 Diabetes in Children and Adolescents. JAMA Psychiatry. 2021 Jan 01; 78(1):91-100. View abstract
  4. Antidiabetic medication use in commercially insured children and adolescents in the United States from 2004 to 2019. Diabetes Obes Metab. 2021 Feb; 23(2):444-454. View abstract
  5. The urgent need for research coordination to advance knowledge on COVID-19 in children. Pediatr Res. 2020 Nov 11. View abstract
  6. Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial. mSphere. 2020 11 04; 5(6). View abstract
  7. Development and Validation of a Pediatric Comorbidity Index. Am J Epidemiol. 2020 Oct 30. View abstract
  8. Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study. Ther Innov Regul Sci. 2021 Mar; 55(2):388-400. View abstract
  9. Association of State-Level Opioid-Reduction Policies With Pediatric Opioid Poisoning. JAMA Pediatr. 2020 Oct 01; 174(10):961-968. View abstract
  10. Pediatric Drug Policies Supporting Safe And Effective Use Of Therapeutics In Children: A Systematic Analysis. Health Aff (Millwood). 2020 Oct; 39(10):1799-1805. View abstract
  11. Landscape of phase 1 clinical trials for minors with cancer in the United States. Pediatr Blood Cancer. 2020 11; 67(11):e28694. View abstract
  12. Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19). JAMA Pediatr. 2020 Sep 01; 174(9):825-826. View abstract
  13. Assessing the quality of nontraditional N95 filtering face-piece respirators available during the COVID-19 pandemic. medRxiv. 2020 Jul 27. View abstract
  14. Personal Protective Equipment for COVID-19: Distributed Fabrication and Additive Manufacturing. Am J Public Health. 2020 08; 110(8):1162-1164. View abstract
  15. Is it time for computable evidence synthesis? J Am Med Inform Assoc. 2020 06 01; 27(6):972-975. View abstract
  16. Increasing Access to FDA Inspection Reports on Irregularities and Misconduct in Clinical Trials. JAMA. 2020 May 19; 323(19):1903-1904. View abstract
  17. Sponsorship of oncology clinical trials in the United States according to age of eligibility. Cancer Med. 2020 07; 9(13):4495-4500. View abstract
  18. Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE: a quality improvement study. medRxiv. 2020 Apr 23. View abstract
  19. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec; 25(6):213-219. View abstract
  20. Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers. J Natl Cancer Inst. 2020 03 01; 112(3):224-228. View abstract
  21. Improving Pediatric Academic Global Health Collaborative Research and Agenda Setting: A Mixed-Methods Study. Am J Trop Med Hyg. 2020 03; 102(3):649-657. View abstract
  22. Off-label use of prescription analgesics among hospitalized children in the United States. Pharmacoepidemiol Drug Saf. 2020 04; 29(4):474-481. View abstract
  23. Correction: The Genomics Research and Innovation Network: creating an interoperable, federated, genomics learning system. Genet Med. 2020 Feb; 22(2):449. View abstract
  24. The use of opioids in low acuity pediatric trauma patients. PLoS One. 2019; 14(12):e0226433. View abstract
  25. Developing a pediatric pain data repository. JAMIA Open. 2020 Apr; 3(1):31-36. View abstract
  26. Noncompletion and nonpublication of trials studying rare diseases: A cross-sectional analysis. PLoS Med. 2019 11; 16(11):e1002966. View abstract
  27. Prescription opioid use and misuse among adolescents and young adults in the United States: A national survey study. PLoS Med. 2019 11; 16(11):e1002922. View abstract
  28. The Genomics Research and Innovation Network: creating an interoperable, federated, genomics learning system. Genet Med. 2020 02; 22(2):371-380. View abstract
  29. Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation. N Engl J Med. 2019 08 29; 381(9):875-881. View abstract
  30. Importance of authorship and inappropriate authorship assignment in paediatric research in low- and middle-income countries. Trop Med Int Health. 2019 10; 24(10):1229-1242. View abstract
  31. Trends in Opioid Prescribing for Adolescents and Young Adults in Ambulatory Care Settings. Pediatrics. 2019 06; 143(6). View abstract
  32. Cost Implications of Escalating Intravenous Acetaminophen Use in Children. JAMA Pediatr. 2019 05 01; 173(5):489-491. View abstract
  33. Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 02; 38(2):313-319. View abstract
  34. The timing and frequency of trial inclusion in systematic reviews of type 2 diabetes drugs was associated with trial characteristics. J Clin Epidemiol. 2019 05; 109:62-69. View abstract
  35. Neglected tropical diseases in children: An assessment of gaps in research prioritization. PLoS Negl Trop Dis. 2019 01; 13(1):e0007111. View abstract
  36. Trial2rev: Combining machine learning and crowd-sourcing to create a shared space for updating systematic reviews. JAMIA Open. 2019 Apr; 2(1):15-22. View abstract
  37. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act. JAMA Pediatr. 2019 01 01; 173(1):68-74. View abstract
  38. Registration of published randomized trials: a systematic review and meta-analysis. BMC Med. 2018 10 16; 16(1):173. View abstract
  39. Availability of paediatric information in European Medicines Agency approvals. Lancet Child Adolesc Health. 2018 05; 2(5):e9. View abstract
  40. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med. 2018 03; 15(3):e1002520. View abstract
  41. A shared latent space matrix factorisation method for recommending new trial evidence for systematic review updates. J Biomed Inform. 2018 03; 79:32-40. View abstract
  42. Prevalence of Disclosed Conflicts of Interest in Biomedical Research and Associations With Journal Impact Factors and Altmetric Scores. JAMA. 2018 01 23; 319(4):408-409. View abstract
  43. Improving the Study of New Medicines for Children With Rare Diseases. JAMA Pediatr. 2018 Jan 01; 172(1):7-9. View abstract
  44. Unreported links between trial registrations and published articles were identified using document similarity measures in a cross-sectional analysis of ClinicalTrials.gov. J Clin Epidemiol. 2018 03; 95:94-101. View abstract
  45. Development of the Precision Link Biobank at Boston Children's Hospital: Challenges and Opportunities. J Pers Med. 2017 Dec 15; 7(4). View abstract
  46. Variation in Pediatric Procedural Sedations Across Children's Hospital Emergency Departments. Hosp Pediatr. 2018 01; 8(1):36-43. View abstract
  47. The Evolution of Patient Diagnosis: From Art to Digital Data-Driven Science. JAMA. 2017 Nov 21; 318(19):1859-1860. View abstract
  48. Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis. Pharmacoepidemiol Drug Saf. 2018 02; 27(2):161-167. View abstract
  49. Variation in the evaluation of testicular conditions across United States pediatric emergency departments. Am J Emerg Med. 2018 Feb; 36(2):208-212. View abstract
  50. A systematic review of the processes used to link clinical trial registrations to their published results. Syst Rev. 2017 07 03; 6(1):123. View abstract
  51. Conclusions in systematic reviews of mammography for breast cancer screening and associations with review design and author characteristics. Syst Rev. 2017 05 22; 6(1):105. View abstract
  52. Complexity and Severity of Pediatric Patients Treated at United States Emergency Departments. J Pediatr. 2017 07; 186:145-149.e1. View abstract
  53. Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease. J Am Geriatr Soc. 2017 Nov; 65(11):2354-2361. View abstract
  54. The Pediatric Research Equity Act Moves Into Adolescence. JAMA. 2017 01 17; 317(3):259-260. View abstract
  55. Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children. Pediatrics. 2016 09; 138(3). View abstract
  56. Financial competing interests were associated with favorable conclusions and greater author productivity in nonsystematic reviews of neuraminidase inhibitors. J Clin Epidemiol. 2016 12; 80:43-49. View abstract
  57. Emergency Department Management of Febrile Respiratory Illness in Children. Pediatr Emerg Care. 2016 Jul; 32(7):429-34. View abstract
  58. Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials. PLoS One. 2016; 11(5):e0155948. View abstract
  59. Conflict of interest disclosure in biomedical research: A review of current practices, biases, and the role of public registries in improving transparency. Res Integr Peer Rev. 2016; 1. View abstract
  60. Drug-Drug Interactions Among Hospitalized Children Receiving Chronic Antiepileptic Drug Therapy. Hosp Pediatr. 2016 May; 6(5):282-9. View abstract
  61. Effect of Randomized Clinical Trial Findings on Emergency Management. Acad Emerg Med. 2016 Jan; 23(1):36-47. View abstract
  62. Measuring patient-perceived quality of care in US hospitals using Twitter. BMJ Qual Saf. 2016 06; 25(6):404-13. View abstract
  63. Comparison of Drug Utilization Patterns in Observational Data: Antiepileptic Drugs in Pediatric Patients. Paediatr Drugs. 2015 Oct; 17(5):401-10. View abstract
  64. Variation and Trends in Charges for Pediatric Care in Massachusetts Emergency Departments, 2000-2011. Acad Emerg Med. 2015 Oct; 22(10):1164-71. View abstract
  65. Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013. Health Res Policy Syst. 2015 Jun 05; 13:28. View abstract
  66. Identifying Clinical Study Types from PubMed Metadata: The Active (Machine) Learning Approach. Stud Health Technol Inform. 2015; 216:867-71. View abstract
  67. Citations alone were enough to predict favorable conclusions in reviews of neuraminidase inhibitors. J Clin Epidemiol. 2015 Jan; 68(1):87-93. View abstract
  68. Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews. Ann Intern Med. 2014 Oct 07; 161(7):513-8. View abstract
  69. New regulatory paradigms for innovative drugs to treat pediatric diseases. JAMA Pediatr. 2014 Oct; 168(10):879-80. View abstract
  70. Variation in emergency department admission rates in US children's hospitals. Pediatrics. 2014 Sep; 134(3):539-45. View abstract
  71. Premarket safety and efficacy studies for ADHD medications in children. PLoS One. 2014; 9(7):e102249. View abstract
  72. Drug safety in the digital age. N Engl J Med. 2014 Jun 26; 370(26):2460-2. View abstract
  73. Postmarketing trials and pediatric device approvals. Pediatrics. 2014 May; 133(5):e1197-202. View abstract
  74. The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children. PLoS One. 2013; 8(12):e84951. View abstract
  75. Association between pediatric clinical trials and global burden of disease. Pediatrics. 2014 Jan; 133(1):78-87. View abstract
  76. Adult prescription drug use and pediatric medication exposures and poisonings. Pediatrics. 2013 Jul; 132(1):18-27. View abstract
  77. Use of QT-prolonging medications in US emergency departments, 1995-2009. Pharmacoepidemiol Drug Saf. 2014 Jan; 23(1):9-17. View abstract
  78. Analysis of pediatric clinical drug trials for neuropsychiatric conditions. Pediatrics. 2013 Jun; 131(6):1125-31. View abstract
  79. Industry influence in evidence production. J Epidemiol Community Health. 2013 Jul; 67(7):537-8. View abstract
  80. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics. 2012 Aug; 130(2):285-92. View abstract
  81. The role and impact of research agendas on the comparative-effectiveness research among antihyperlipidemics. Clin Pharmacol Ther. 2012 Apr; 91(4):685-91. View abstract
  82. Comparative effectiveness research: an empirical study of trials registered in ClinicalTrials.gov. PLoS One. 2012; 7(1):e28820. View abstract
  83. Factors associated with the use of cervical spine computed tomography imaging in pediatric trauma patients. Acad Emerg Med. 2011 Sep; 18(9):905-11. View abstract
  84. Adverse drug events in the outpatient setting: an 11-year national analysis. Pharmacoepidemiol Drug Saf. 2010 Sep; 19(9):901-10. View abstract
  85. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010 Aug 03; 153(3):158-66. View abstract
  86. Neuroimaging for pediatric head trauma: do patient and hospital characteristics influence who gets imaged? Acad Emerg Med. 2010 Jul; 17(7):694-700. View abstract
  87. Relative impact of influenza and respiratory syncytial virus in young children. Pediatrics. 2009 Dec; 124(6):e1072-80. View abstract
  88. Pediatric adverse drug events in the outpatient setting: an 11-year national analysis. Pediatrics. 2009 Oct; 124(4):e744-50. View abstract
  89. "Left without being seen": a national profile of children who leave the emergency department before evaluation. Ann Emerg Med. 2008 Dec; 52(6):599-605. View abstract
  90. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial. J Med Internet Res. 2008 Mar 14; 10(1):e5. View abstract
  91. The value of patient self-report for disease surveillance. J Am Med Inform Assoc. 2007 Nov-Dec; 14(6):765-71. View abstract
  92. Emergency care for children in pediatric and general emergency departments. Pediatr Emerg Care. 2007 Feb; 23(2):94-102. View abstract
  93. Influenza and other respiratory virus-related emergency department visits among young children. Pediatrics. 2006 Jul; 118(1):e1-8. View abstract
  94. Lumbar puncture ordering and results in the pediatric population: a promising data source for surveillance systems. Acad Emerg Med. 2006 Jul; 13(7):767-73. View abstract
  95. Validation of syndromic surveillance for respiratory infections. Ann Emerg Med. 2006 Mar; 47(3):265.e1. View abstract
  96. Association of race/ethnicity with emergency department wait times. Pediatrics. 2005 Mar; 115(3):e310-5. View abstract
  97. Adult patient visits to children's hospital emergency departments. Pediatrics. 2003 Jun; 111(6 Pt 1):1268-72. View abstract
  98. Retropharyngeal cellulitis in a 5-week-old infant. Pediatrics. 2002 Mar; 109(3):E51. View abstract