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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)

FROM EDITOR-IN-CHIEF 

2-4 537
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 

5-9 412
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 

10-15 466
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 

16-20 330
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 

21-24 224
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

2021-12-01

On the way to patient-centered medicine: RWD instruments

Please, see the report by "On the way to patient-centered medicine: RWD instruments", Frolov M.Yu., Head of the Laboratory of Pharmacoeconomics, Digital Medicine and Artificial Intelligence, NTSILS Volgograd State Medical University, Head of the Expert Group of the Association of Clinical Pharmacologists.

2021-11-24

An electronic recipe platform will be launched in the Kursk region

The administration of the Kursk region has decided to launch an electronic recipe platform in the Kursk region. It is expected that by the beginning of 2022 it will be possible to prescribe digital prescriptions in all public clinics in the region. The project will be launched on the Electronic Prescription platform from Medicata, and Rostelecom will become the operator of the project in the Kursk region.

2021-11-19

Real-World Data / Real-World Evidence: Role in Pharmacoeconomics and Health Technology Assessment

COLLEAGUES, as part of the XXV RUSSIAN ONCOLOGICAL CONGRESS, the 12th symposium "Pharmacoeconomics in Oncology" was held on the topic: "Real World Data / Real World Evidence (RWD / RWE): Role in Pharmacoeconomics and Health Technology Assessment" (https://rosoncoweb.ru/news/society/2021/11/15-1/).

2021-11-19

The Second Annual Scientific-Practical Conference in St. Petersburg, Russia

The Association of Health Technology Assessment Professionals, Association of Russian Clinical Pharmacologists, ISPOR Russia St Petersburg Chapter co-organized the II annual scientific-practical conference “RWD/RWE – Tools for Real Clinical Practice Research: Today and Tomorrow” on September 16, 2021. The conference brought together experts from academia, government, pharmaceutical industry, regulatory, and clinical trials from Russia and other countries to discuss about RWD/RWE. ISPOR Chief Science Officer Dr Richard Willke was invited to give a presentation on ISPOR’s RWE transparency initiative and related efforts. More than 300 people participated in this event. 

2021-11-11

The arrival of innovative personalized technologies requires a shift to value-based purchasing and pricing models

The collection of data from real-world data (RWD) is of great importance for making a decision on the inclusion of innovative personalized technologies - cell, gene therapy, complex genomic profiling (NGS-diagnostics) - in the system of state funding, noted Nuria Musina, Advisor to the Head of the Federal State Budgetary Institution "CECCMP" of the Ministry of Health Russia at the Russian Cancer Congress.
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