myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-15WIWMONmyrwd-18Research ArticleМЕЖДУНАРОДНЫЙ ОПЫТINTERNATIONAL EXPERIENCESENTINEL SYSTEM — электронная система для сбора данных реальной клинической практикиSENTINEL SYSTEM – electronic system for collecting real-world datahttps://orcid.org/0000-0002-0239-1434ЕременкоЕ. О.EremenkoE. O.

Еременко Елена Олеговна — ординатор кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

St. Petersburg

skuggavin@gmail.comБарановаМ. И.BaranovaM. I.

Баранова Марина Ивановна — ассистент кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

St. Petersburg

baranova_m_i@mail.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени И. П. Павлова»РоссияFSBEI HE I. P. Pavlov SPbSMU MOH RussiaRussian Federation202201082022223240Copyright © Еременко Е.О., Баранова М.И., 20222022Еременко Е.О., Баранова М.И.Eremenko E.O., Baranova M.I.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/18

Потребность использования всё большего количества данных для генерирования доказательств в ответ на новые вызовы клинической медицины требует от системы здравоохранения определённых ответных мер. Высокий темп развития медицины, ускорение разработки новых лекарственных средств в ответ на возрастающие потребности клиницистов для лечения пациентов приводит к необходимости быстрой оценки результатов лечения, эффективности и безопасности новых лекарственных средств. Разработка инструмента для централизованного сбора данных об эффективности и безопасности, способная объединить как можно больше клинических центров: больниц, частных медицинских центров, научных институтов, — является приоритетной задачей системы здравоохранения для реализации этих ответных мер. Примером подобного рода разработки системы координации сбора данных и их анализа является разработанная в 2007 году Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов (Food and Drug Administration, FDA) инициатива Sentinel.

Sentinel — это национальная электронная система, которая изменила способ, которым исследователи контролируют безопасность медицинских продуктов, регулируемых FDA, включая лекарства, вакцины, биологические препараты и медицинские устройства. Мониторинг безопасности регулируемых продуктов является важной частью миссии FDA по защите здоровья населения.

Настоящий обзор посвящён истории развития, организационной структуре, принципам работы и демонстрации некоторых проектов системы Sentinel. В рамках обзора будут рассмотрены как проекты, разрабатываемые для применения в рамках общеклинических проблем (применение в уязвимых группах пациентов, пациентов с заболеваниями почек и др.), так и проекты, разрабатываемые в ответ на потребности исследователей, возникшие в эпоху пандемии COVID-19.

The need to use more and more data to generate evidence in response to new challenges in clinical medicine requires a specific response from the healthcare system. The high pace of development of medicine, the acceleration of the development of new drugs in response to the increasing needs of clinicians for treating patients leads to the need for a rapid assessment of treatment outcomes, efficacy and safety of new drugs. The development of a tool for centralized collection of data on efficacy and safety, capable of connecting as many clinical centers as possible: hospitals, private medical centers, scientific institutions — is a priority for the health system to implement these responses. An example of this type of data collection and analysis coordination system development is the 2007 Food a nd Drug Administration (FDA) Sentinel initiative.

Sentinel is a national electronic system that has changed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. Monitoring the safety of regulated products is an important part of the FDA»s mission to protect public health.

This review is devoted to the history of development, organizational structure, principles of operation and demonstration of some projects of the Sentinel system. The review will consider both projects developed for application within the framework of general clinical problems (use in vulnerable groups of patients, patients with kidney diseases, etc.), and projects developed in response to the needs of researchers that have arisen in the era of the COVID-19 pandemic.

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