Using Registers to Study Effectiveness and Safety of Drugs
https://doi.org/10.17650/1818-8338-2012-3-4-4-9
Abstract
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 many
cases 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.
About the Authors
L. Yu. Drozdova
National Research Center for Preventive Medicine
Russian National Society of Evidence-Based Pharmacotherapy
Russian Federation
Russian Federation
N. P. Kutishenko
National Research Center for Preventive Medicine
Russian National Society of Evidence-Based Pharmacotherapy
Russian Federation
Russian Federation
M. L. Ginzburg
National Research Center for Preventive Medicine
Russian National Society of Evidence-Based Pharmacotherapy
Lyuberetsy district hospital No.2
Russian Federation
Russian Federation
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Review
For citations:
Drozdova L.Yu., Kutishenko N.P., Ginzburg M.L. Using Registers to Study Effectiveness and Safety of Drugs. The Clinician. 2012;6(3-4):4-9. (In Russ.) https://doi.org/10.17650/1818-8338-2012-3-4-4-9
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