rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2016-12-5-567-573rpcardio-1338Research ArticlePAGES OF RUSSIAN NATIONAL SOCIETY OF EVIDENCE-BASED PHARMACOTHERAPYСТРАНИЦЫ НАЦИОНАЛЬНОГО ОБЩЕСТВА ДОКАЗАТЕЛЬНОЙ ФАРМАКОТЕРАПИИRandomised Clinical Trials and Observational Studies: the Ratio in the Hierarchy of Evidence of the Efficacy of DrugsРандомизированные клинические исследования и наблюдательные исследования: соотношение в иерархии доказательств эффективности лекарствМарцевичС. Ю.MartsevichS. Yu.

д.м.н., профессор, руководитель отдела профилактической фармакотерапии ГНИЦ ПМ

MD, PhD, Professor, Head of the Department of Preventive Pharmacotherapy, State Research Center for Preventive Medicine

SMartsevich@gnicpm.ruКутишенкоН. П.KutishenkoN. P.

д.м.н., руководитель лаборатории фармакоэпидемиологических исследований отдела профилактической фармакотерапии ГНИЦ ПМ

MD, PhD, Head of Laboratory for Pharmacoepidemiological Research of the Department of Preventive Pharmacotherapy, State Research Center for Preventive Medicine

Государственный научно-исследовательский центр профилактической медицины Россия, 101990, Москва, Петроверигский пер., 10, стр 3РоссияState Research Center for Preventive Medicine. Petroverigsky per. 10-3, Moscow, 101990, RussiaRussian Federation201606112016125567573Copyright © Martsevich S.Y., Kutishenko N.P., 20162016Марцевич С.Ю., Кутишенко Н.П.Martsevich S.Y., Kutishenko N.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/1338

The role of randomized controlled trials (RCTs) and observational studies in evaluation of the efficacy and safety of cardiology drugs is compared in the article. The clear conclusion is made that RCTs are the basis of modern evidence-based medicine, and that they have no alternative. Observational studies conducted in compliance with the modern rules can be a source of information on the efficacy of drugs only in the absence of data from RCTs.

В статье сравнивается роль рандомизированных контролируемых исследований (РКИ) и наблюдательных исследований в оценке эффективности и безопасности лекарственных средств в области кардиологии. Делается однозначный вывод о том, что РКИ являются основой современной доказательной медицины, и что им нет альтернативы. Наблюдательные исследования, проведенные с соблюдением современных правил, могут служить источником информации об эффективности лекарств лишь в отсутствие данных РКИ.

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