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Real-World Data & Evidence

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The journal “Real-world data & evidence” aims to publish original research and reviews on the use of real-world data (RWD) to assess treatment outcomes and make health decisions. 

Articles published in the journal “Real-world data & evidence” cover, but are not limited, key research areas, such as registers, medical databases, electronic medical records, drug use and outcomes in routine medical practice, drugs prescription, drugs safety, adherence, comparative effectiveness research, pharmacoeconomics and outcomes research, including the cost-of-illness analysis, pragmatic clinical trials, exploring research methodology based on RWD, including collecting, tracking, searching, sharing, analyzing and interpreting Big Data.

Also, the journal website www.MyRWD.ru published news about the research carried out in real-world clinical practice, and conferences, congresses and other events announcements.

The journal "Real-world data & evidence" - it is a system of online publications: after the completion of the work on the manuscript, it published on the journal's website as soon as possible with the assignment of a DOI. Once published online, no changes can be made to the manuscript. Every three months, all manuscripts published during this period on the site, combined into a current issue. Before the release of the current issue of the journal, authors can print the articles published on the site, which will contain the necessary output data.

Current issue

Vol 1, No 1 (2021)
View or download the full issue PDF (Russian) | PDF

FROM EDITOR-IN-CHIEF 

765
Abstract

The modern request of the global healthcare system is the collection and analysis of the information obtained during the analysis of data collected in research of routine medical practice, namely real-world data (RWD), and the evidence based on it, real-world evidence (RWE).

DRUG SAFETY 

664
Abstract

The relevance of paracetamol safety assessment is associated with broad recommendations for its use as a symptomatic agent in COVID-19 and an agent for adverse events following vaccination to prevent COVID-19.

Objectives. Conducting a review of global paracetamol safety data during the initial period of COVID-19 pandemic (in 2020 and in the first half of 2021).

Materials and methods. 2,356 scientific articles and their abstracts on paracetamol safety in electronic libraries; data on 2,272 clinical trials of paracetamol in ClinicalTrials.gov and the State Register of Medicines of the Ministry of Health of the Russian Federation; 173,707 individual reports of adverse drugs reactions of paracetamol in the international pharmacovigilance database VigiBase. The data were evaluated by statistical methods in the VigiLyze analytical system (authorized expert access).

Results. No publications and completed clinical trials were found on the safety issue of paracetamol use in COVID-19. During the initial period of COVID-19 pandemic (from January 1, 2020 to July 31, 2021), the number of reports of paracetamol safety issues included in VigiBase decreased by 22,1%, which may be due to a decrease in the number of specialists sending reports on safety, with an increase of their duties and with a switching attention of these specialists and patients to other problems associated with the COVID-19 pandemic. No changes have been identified in the sources of safety data and trade names for paracetamol medicinal products. It has been established that the main part (99,4% of cases) of side effects associated with paracetamol develops outside the use of vaccines for the prevention of COVID-19. Pre-COVID and COVID data include information on 2,692 and 2,527 names of various paracetamol safety concerns, respectively. These data overlap the list of side effects specified in instructions for medical use and include new symptoms not described in instructions for medical use.

Conclusions. The lack of safety signals may be due to the lack of alertness of specialists and marketing authorization holders regarding paracetamol. During the COVID period, the structure and frequency of paracetamol safety concerns codified in terms of MedDRA (version 24.0) have changed, which can be studied in future studies of paracetamol, ibuprofen and other medicinal products.

CLINICAL REGISTERS 

677
Abstract

The development of medical science requires a constant increase in the effectiveness and safety of treatment. Collection of real-world data (RWD) is one way of solving these problems. Clinical registries are one of the most important parts of this process. Clinical registries allow collecting data on the use of medical technologies and monitoring the results of therapy in real clinical practice. The introduction of patient registers and the collection of RWD data into widespread medical practice can help to optimize costs in the treatment of high-cost diseases and to better plan the budget.

PUBLIC PROCUREMENT 

518
Abstract

The article describes the approaches of law enforcement practice in relation to the regulatory limits within which a medical institution may exercise it's right to establish requirements for purchased drugs based on purchaser's clinical practice and its own clinical experience.

RESOLUTION 

417
Abstract

On September 16, 2021, the Association of Health Technology Assessment Professionals, the Association of Russian Clinical Pharmacologists, St. Petersburg Branch of ISPOR organized the II annual scientific and practical conference with international participation: "RWD/RWE – Research Tools of Real-World Clinical Practice Today and Tomorrow". The topic of the conference brought together leading Russian and world experts in the field of RWD/RWE. 

News

2022-01-20

RWD as a tool for making decisions when making changes regarding the safety / efficacy of a medicinal product in the instructions for medical use and during registration

Please, see the report by "RWD as a tool for making decisions when making changes regarding the safety / efficacy of a medicinal product in the instructions for medical use and during registration", V. Merkulov, Deputy General Director of the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia, MD, Professor.

2022-01-20

Assessment of the prospects and barriers to the use of electronic medical records as a source of data for real clinical practice

Please, see the report by "Assessment of the prospects and barriers to the use of electronic medical records as a source of data for real clinical practice", Gusev AV, Director of Business Development, Ph.D., Webiomed.

2022-01-20

Technologies of personalized medicine: the view of a clinical pharmacologist

Please, see the report by "Technologies of personalized medicine: the view of a clinical pharmacologist", DA Sychev, Head of the Department of Clinical Pharmacology and Therapy, Rector of the RMANPO of the Ministry of Health of the Russian Federation, Doctor of Medical Sciences, Professor Corresponding Member of the Russian Academy of Sciences

2022-01-11

RWD / RWE and pediatric routine - is there a connection?

Please, see the report by "RWD / RWE and pediatric routine - is there a connection?" Namazova-Baranova L.S., President of the Union of Pediatricians of Russia, Head of the Department of Faculty Pediatrics, Faculty of Pediatrics, N.I. Pirogov of the Ministry of Health of Russia, Chief Freelance Specialist for Children in Preventive Medicine of the Ministry of Health of Russia, Professor, Doctor of Medical Sciences, Academician of the Russian Academy of Sciences.

2022-01-11

Impact of the COVID-19 pandemic on microbial resistance in the Russian Federation

Please, see the report by "Impact of the COVID-19 pandemic on microbial resistance in the Russian Federation", RS Kozlov, Corresponding Member of the Russian Academy of Sciences, Professor, Doctor of Medical Sciences, Rector of the Smolensk State Medical University of the Ministry of Health of the Russian Federation. Chief freelance specialist of the Ministry of Health of the Russian Federation in clinical microbiology and antimicrobial resistance. Head of the WHO Collaborating Center for Strengthening Capacity in Antimicrobial Resistance Surveillance and Research.

2022-01-11

Digital technologies in assessing the practice of drug use

Please, see the report by "Digital technologies in assessing the practice of drug use", Khokhlov AL, Head of the YSMU Department of the Ministry of Health of Russia, Chief Clinical Pharmacologist of the Yaroslavl Region and the Central Federal District of the Russian Federation, Professor, Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences.

2022-01-11

RWD in the paradigm of clinical guidelines

Please, see the report by "RWD in the paradigm of clinical guidelines", O. Sukhorukikh, Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation

2021-12-30

AIPM RWE Working Group

Please, see the report by «AIPM RWE Working Group», T. Goldina, Head of Real Clinical Practice Data and Scientific Communication, Sanofi

2021-12-29

Research of real clinical practice in the field of Pulmonary arterial hypertension

Please, see the report by "Research of real clinical practice in the field of Pulmonary arterial hypertension", Ryazhenov V.V., Head of the Department of Regulatory Relations in the field of circulation of medicines and medical devices of the First Moscow State Medical University named after THEM. Sechenov. "

2021-12-29

Problems of including RWD / RWE data in the justification for registration of a medicinal product

Please, see the report by "Problems of including RWD / RWE data in the justification for registration of a medicinal product", Rozhdestvensky D.A., Eurasian Economic Commission, Head of the Department for Coordination of Work in the Sphere of Circulation of Medicines and Medical Devices, Department of Technical Regulation and Accreditation

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