clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИclinvest-344Research ArticleКАЧЕСТВО ЖИЗНИQUALITY OF LIFEКачество жизни, связанное со здоровьем детей: обзор литературыhttps://orcid.org/0000-0002-2164-8290БелоусовД. Ю.

генеральный директор

SPIN-код: 6067-9067

clinvest@mail.ruООО "Центр фармакоэкономических исследований", г. МоскваRussian Federation200828062018022838Copyright © Белоусов Д.Ю., 20182018Белоусов Д.Ю.Белоусов Д.Ю.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/344

Исторически, дети редко участвовали в исследованиях препаратов, что может быть связано со сложностью использования детей как объектов медицинских исследований. В отсутствие контролируемых клинических исследований с участием детей врачи и родители не могли быть уверены во многих эффектах лечения этой категории больных. Поэтому регулирующие органы США и Европы недавно приняли ряд нормативных документов, способствующих исследованию эффектов препаратов у детей в качестве компонента клинической разработки лекарств.

Фармацевтические компании откликнулись на это увеличением количества исследований с участием детей. Эти исследования были направлены в основном на изучение эффективности и безопасности, и лишь в относительно небольшом их количестве оценивалось влияние лечения на качество жизни, связанного со здоровьем детей – Health-Related Quality of Life / HRQoL (далее по тексту КЖ). Как и у взрослых, эффекты заболеваний и лечения детей выходят за физиологические рамки.

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