Big Data in the Assessment of Pediatric Medication Safety.
Big data (BD) in pediatric medication safety research provides many opportunities to improve the safety and health of children. The number of pediatric medication and device trials has increased in part because of the past 20 years of US legislation requiring and incentivizing study of the effects o...
| Publicado en: | Pediatrics Vol. 145; no. 2; pp. 1 - 10 |
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| Autores principales: | , , , , , , , , , , , , , |
| Formato: | pictorial Journal Article |
| Publicado: |
American Academy of Pediatrics
Feb2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=141678198&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 141678198 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00314005 PDT jtl: Pediatrics issn: 00314005 maglogo: N pubinfo: dt: Feb2020 vid: 145 iid: 2 pid: 1659 pub: American Academy of Pediatrics place: Elk Grove Village, Illinois artinfo: ui: 141678198 141678198 141678198 10.1542/peds.2019-0562 141678198 ppf: 1 ppct: 9 formats: tig: atl: Big Data in the Assessment of Pediatric Medication Safety. aug: au: McMahon, Ann W. Cooper, William O. Brown, Jeffrey S. Carleton, Bruce Doshi-Velez, Finale Kohane, Isaac Goldman, Jennifer L. Hoffman, Mark A. Kamaleswaran, Rishikesan Michiyo Sakiyama Shohko Sekine Sturkenboom, Miriam C. J. M. Turner, Mark A. Califf, Robert M. affil: Office of Pediatric Therapeutics, US Food and Drug Administration, Rockville, Maryland sug: subj: Data Analytics Utilization Medication Errors Prevention and Control Patient Safety Pediatrics Child Safety Research, Medical Seminars and Workshops ab: Big data (BD) in pediatric medication safety research provides many opportunities to improve the safety and health of children. The number of pediatric medication and device trials has increased in part because of the past 20 years of US legislation requiring and incentivizing study of the effects of medical products in children (Food and Drug Administration Modernization Act of 1997, Pediatric Rule in 1998, Best Pharmaceuticals for Children Act of 2002, and Pediatric Research Equity Act of 2003). There are some limitations of traditional approaches to studying medication safety in children. Randomized clinical trials within the regulatory context may not enroll patients who are representative of the general pediatric population, provide the power to detect rare safety signals, or provide long-term safety data. BD sources may have these capabilities. In recent years, medical records have become digitized, and cell phones and personal devices have proliferated. In this process, the field of biomedical science has progressively used BD from those records coupled with other data sources, both digital and traditional. Additionally, large distributed databases that include pediatric-specific outcome variables are available. A workshop entitled "Advancing the Development of Pediatric Therapeutics: Application of 'Big Data' to Pediatric Safety Studies" held September 18 to 19, 2017, in Silver Spring, Maryland, formed the basis of many of the ideas outlined in this article, which are intended to identify key examples, critical issues, and future directions in this early phase of an anticipated dramatic change in the availability and use of BD. pubtype: Academic Journal doctype: pictorial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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