Using Registers to Study Effectiveness and Safety of Drugs

The article discusses the main aspects of registers use to evaluate the effectiveness and safety of drugs. It is noted that the results of the randomized clinical trials are currently constitute the highest level of evidence in medicine, but they have several limitations. Besides, in manycases evide...

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Main Authors: L. Yu. Drozdova, N. P. Kutishenko, M. L. Ginzburg
Format: Article
Language:Russian
Published: ABV-press 2014-07-01
Series:Klinicist
Subjects:
Online Access:https://klinitsist.abvpress.ru/Klin/article/view/47
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author L. Yu. Drozdova
N. P. Kutishenko
M. L. Ginzburg
author_facet L. Yu. Drozdova
N. P. Kutishenko
M. L. Ginzburg
author_sort L. Yu. Drozdova
collection DOAJ
description The article discusses the main aspects of registers use to evaluate the effectiveness and safety of drugs. It is noted that the results of the randomized clinical trials are currently constitute the highest level of evidence in medicine, but they have several limitations. Besides, in manycases evidence based on the results of the randomized clinical trials (RCTs) is simply missing. In this connection need for observational studies that, despite some limitations often supplement the information obtained in the RCT is discussed. Registers as the way to study the effectiveness and safety of drugs could help overcome some limitations of observational studies. The examples of both Russian and foreign studies held within registers in order to study the effectiveness of drugs in cardiology are provided. The framework for RCTs and registries contribution in studying effectiveness and safety of a drug is proposed.
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spelling doaj.art-b72dacd7c08b4f1ea4a0af97a4be6f092023-03-30T20:14:07ZrusABV-pressKlinicist1818-83382014-07-0163-44910.17650/1818-8338-2012-3-4-4-962Using Registers to Study Effectiveness and Safety of DrugsL. Yu. Drozdova0N. P. Kutishenko1M. L. Ginzburg2National Research Center for Preventive Medicine Russian National Society of Evidence-Based PharmacotherapyNational Research Center for Preventive Medicine Russian National Society of Evidence-Based PharmacotherapyNational Research Center for Preventive Medicine Russian National Society of Evidence-Based Pharmacotherapy Lyuberetsy district hospital No.2The article discusses the main aspects of registers use to evaluate the effectiveness and safety of drugs. It is noted that the results of the randomized clinical trials are currently constitute the highest level of evidence in medicine, but they have several limitations. Besides, in manycases evidence based on the results of the randomized clinical trials (RCTs) is simply missing. In this connection need for observational studies that, despite some limitations often supplement the information obtained in the RCT is discussed. Registers as the way to study the effectiveness and safety of drugs could help overcome some limitations of observational studies. The examples of both Russian and foreign studies held within registers in order to study the effectiveness of drugs in cardiology are provided. The framework for RCTs and registries contribution in studying effectiveness and safety of a drug is proposed.https://klinitsist.abvpress.ru/Klin/article/view/47registerrandomized clinical trialsobservational studieseffectiveness of drugs
spellingShingle L. Yu. Drozdova
N. P. Kutishenko
M. L. Ginzburg
Using Registers to Study Effectiveness and Safety of Drugs
Klinicist
register
randomized clinical trials
observational studies
effectiveness of drugs
title Using Registers to Study Effectiveness and Safety of Drugs
title_full Using Registers to Study Effectiveness and Safety of Drugs
title_fullStr Using Registers to Study Effectiveness and Safety of Drugs
title_full_unstemmed Using Registers to Study Effectiveness and Safety of Drugs
title_short Using Registers to Study Effectiveness and Safety of Drugs
title_sort using registers to study effectiveness and safety of drugs
topic register
randomized clinical trials
observational studies
effectiveness of drugs
url https://klinitsist.abvpress.ru/Klin/article/view/47
work_keys_str_mv AT lyudrozdova usingregisterstostudyeffectivenessandsafetyofdrugs
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