Cargando…

In the Real-World, Kids Use Medications and Devices

In the real world, we lack evidence guiding the use of medications and devices in children. This lack of evidence arose out of the challenges of conducting clinical trials in children and other vulnerable populations and the historical decision (reversed in recent decades) to exclude children from c...

Descripción completa

Detalles Bibliográficos
Autor principal: Lasky, Tamar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457309/
https://www.ncbi.nlm.nih.gov/pubmed/28516334
http://dx.doi.org/10.1007/s40801-017-0106-9
_version_ 1783241516964118528
author Lasky, Tamar
author_facet Lasky, Tamar
author_sort Lasky, Tamar
collection PubMed
description In the real world, we lack evidence guiding the use of medications and devices in children. This lack of evidence arose out of the challenges of conducting clinical trials in children and other vulnerable populations and the historical decision (reversed in recent decades) to exclude children from clinical trials. The recent focus on the potential of real-world evidence (RWE) to guide approval and use of new treatments may provide a much-needed solution. A broad definition of RWE includes prospective observational data and data from electronic health records and claims, as well as other sources. For the most part, it is reasonable to expect that considerations around the use of RWE in adult populations will apply to its use in children. However, a number of issues around the use of RWE are unique to studying children. These fall into at least four categories: (1) identification of databases with adequate numbers of children in the age sub-groups of interest, (2) access to critical variables such as birth date, birth weight, and gestational age, (3) linkage to parental records for information about pre-natal exposures, family history, and socio-economic status, and (4) linkage to school records for information about outcomes such as missed school days, academic progress, and behavioral issues. Addressing the needs of children in developing methodologies for use of RWE ensures that ongoing efforts will benefit children as well as other sectors of the population.
format Online
Article
Text
id pubmed-5457309
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-54573092017-06-16 In the Real-World, Kids Use Medications and Devices Lasky, Tamar Drugs Real World Outcomes Commentary In the real world, we lack evidence guiding the use of medications and devices in children. This lack of evidence arose out of the challenges of conducting clinical trials in children and other vulnerable populations and the historical decision (reversed in recent decades) to exclude children from clinical trials. The recent focus on the potential of real-world evidence (RWE) to guide approval and use of new treatments may provide a much-needed solution. A broad definition of RWE includes prospective observational data and data from electronic health records and claims, as well as other sources. For the most part, it is reasonable to expect that considerations around the use of RWE in adult populations will apply to its use in children. However, a number of issues around the use of RWE are unique to studying children. These fall into at least four categories: (1) identification of databases with adequate numbers of children in the age sub-groups of interest, (2) access to critical variables such as birth date, birth weight, and gestational age, (3) linkage to parental records for information about pre-natal exposures, family history, and socio-economic status, and (4) linkage to school records for information about outcomes such as missed school days, academic progress, and behavioral issues. Addressing the needs of children in developing methodologies for use of RWE ensures that ongoing efforts will benefit children as well as other sectors of the population. Springer International Publishing 2017-05-17 /pmc/articles/PMC5457309/ /pubmed/28516334 http://dx.doi.org/10.1007/s40801-017-0106-9 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Commentary
Lasky, Tamar
In the Real-World, Kids Use Medications and Devices
title In the Real-World, Kids Use Medications and Devices
title_full In the Real-World, Kids Use Medications and Devices
title_fullStr In the Real-World, Kids Use Medications and Devices
title_full_unstemmed In the Real-World, Kids Use Medications and Devices
title_short In the Real-World, Kids Use Medications and Devices
title_sort in the real-world, kids use medications and devices
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457309/
https://www.ncbi.nlm.nih.gov/pubmed/28516334
http://dx.doi.org/10.1007/s40801-017-0106-9
work_keys_str_mv AT laskytamar intherealworldkidsusemedicationsanddevices