Assessing Drug Safety in Children — The Role of Real-World Data

There are substantial gaps in evidence regarding the safety of many drugs in children. Increasingly, studies assessing drug safety can incorporate data obtained in the course of clinical care to generate real-world evidence and help fill these gaps.

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Bibliographic Details
Published in:	The New England journal of medicine Vol. 378; no. 23; pp. 2155 - 2157
Main Authors:	McMahon, Ann W, Dal Pan, Gerald
Format:	Journal Article
Language:	English
Published:	United States Massachusetts Medical Society 07-06-2018
Subjects:	Adults Advisory Committees Cancer Child Children Children & youth Chronic illnesses Clinical trials Consumer Product Safety - legislation & jurisprudence Design Disclosure Drug-Related Side Effects and Adverse Reactions Electronic health records Health insurance Humans Inflammatory bowel disease Legislation, Drug Maternal & child health Medical Device Legislation Medical equipment Medical records Objectives Pediatrics Pharmaceuticals Pharmacovigilance Prescription drugs Product safety Product Surveillance, Postmarketing Safety Substance abuse treatment United States United States Food and Drug Administration - legislation & jurisprudence United States > US
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Description
Summary:	There are substantial gaps in evidence regarding the safety of many drugs in children. Increasingly, studies assessing drug safety can incorporate data obtained in the course of clinical care to generate real-world evidence and help fill these gaps.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp1802197