Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations - 23/10/21
Doi : 10.1016/j.jpeds.2021.06.062
Daniel B. Horton, MD, MSCE 1, 2, 3, ⁎ 
, Michael D. Blum, MD, MPH 4, Mehmet Burcu, PhD, MS 5
, Michael D. Blum, MD, MPH 4, Mehmet Burcu, PhD, MS 5 1 Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ
2 Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, NJ
3 Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ
4 Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
5 Department of Epidemiology, Merck & Co., Inc., Kenilworth, NJ
∗Reprint requests: Daniel B. Horton, MD, MSCE, Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, 112 Paterson St, New Brunswick, NJ 08901.Department of PediatricsRutgers Robert Wood Johnson Medical School112 Paterson StNew BrunswickNJ08901
Keywords : real-world data, observational research, electronic health records, administrative claims data, pharmacoepidemiology, pediatric
Abbreviations : EHR, FDA, RCT, RWD, RWE
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| This article is endorsed by the International Society for Pharmacoepidemiology (ISPE). D.H. is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health (K23AR070286 and R01AR074436) and received grant funding from Danisco USA Inc. M.Bu. is a full-time employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and holds stock in Merck & Co., Inc., Kenilworth, NJ, USA. M.Bl. declares no conflicts of interest. This article reflects the views and opinions of the authors and should not be construed to represent the views and opinions of the US government, the US Food and Drug Administration, the National Institutes of Health, or any other public or private entity, who had no role in the writing of the report or the decision to submit the paper for publication. |
© 2021
Elsevier Inc. Tous droits réservés.
Vol 238
P. 312-316 - novembre 2021 Retour au numéro
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