myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-31HOPBUPmyrwd-36Research ArticleМЕЖДУНАРОДНЫЙ ОПЫТINTERNATIONAL EXPERIENCEОбзор руководств от FDA для вовлечения пациента в процесс разработки медицинских продуктов и принятия нормативных решенийOverview of FDA guidelines for patient engagement in medical product development and regulatory decision makinghttps://orcid.org/0000-0002-4180-0878БоровскаяВ. Г.BorovskayaV. G.

Боровская Валентина Геннадьевна — врач-терапевт, ординатор кафедры клинической фармакологии и доказательной медицины

РИНЦ AuthorID: 1106529

Санкт-Петербург

Borovskaya Valentina G. — resident of the department of Clinical Pharmacology and Evidence-Based Medicine

RSCI AuthorID: 1106529

St. Petersburg

valentine.borovskaya@gmail.comhttps://orcid.org/0000-0001-6284-7133КасимоваА. Р.KasimovaA. R.

Касимова Алина Рашидовна — к. м. н., доцент кафедры клинической фармакологии и доказательной медицины, ФГБОУ ВО ПСПбГМУ им. И. П. Павлова Минздрава России; врач — клинический фармаколог отделения клинической фармакологии ФГБУ НМИЦ ТО им. Р. Р. Вредена

РИНЦ AuthorID: 913606

Санкт-Петербург

Kasimova Alina R. — PhD, associate professor of the department of Clinical Pharmacology and Evidence-Based Medicine Pavlov First Saint Petersburg State Medical University; Clinical pharmacologist of the Department of Clinical Pharmacology Russian Scientific Research Institute of Traumatology and Orthopedics named after R. R. Vreden

RSCI AuthorID: 913606

St. Petersburg

kasi-alina@yandex.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И. П. Павлова»РоссияFederal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian FederationRussian FederationФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И. П. Павлова»; ФГБУ «Национальный медицинский исследовательский центр травматологии и ортопедии имени Р. Р. Вредена» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Educational Institution of Higher Education «First St. Petersburg State Medical University named after Academician I. P. Pavlov» of the Ministry of Health of the Russian Federation; Federal State Budgetary Institution «National Medical Research Center for Traumatology and Orthopedics named after R. R. Vreden» of the Ministry of Health of the Russian FederationRussian Federation2023300820233219Copyright © Боровская В.Г., Касимова А.Р., 20232023Боровская В.Г., Касимова А.Р.Borovskaya V.G., Kasimova A.R.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/36

Около 10 лет назад FDA выступило с инициативой по расширению роли пациентов в информировании регулирующих органов и спонсоров о наиболее серьёзных последствиях заболевания и основных целях лечения, которые могут привести к желаемым медицинским исходам. На данный момент эта инициатива переросла в четыре руководства, целью которых является учесть мнение пациента при разработке лекарственных средств. Это формирует цель статьи – сформулировать собственное описание информационного общества, включающее определение и перечисление ключевых характеристик. Цель является базой для задачи статьи: подготовить теоретическую базу для дальнейшего, более углубленного исследования перспектив развития информационного общества.

About 10 years ago, the FDA launched an initiative to expand the role of patients in informing regulators and sponsors about the most serious consequences of the disease and the main treatment goals that can lead to desired medical outcomes. This initiative has grown into four guidance that aim.

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The authors declare that there are no conflicts of interest present.