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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...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2017
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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 |
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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 |