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Real-World Data & Evidence

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Editorial Policies

Aim and Scope

Randomized clinical trials (RCTs) are the gold standard in evidence-based medicine, but by the nature of their design, they cannot provide doctors with complete information in many areas. While RCTs provide evidence of efficacy and safety for subsequent drug registration, they exclude many relevant patient populations, such as the elderly, children, and those with underlying medical conditions, and are conducted under “ideal” conditions with the expectation of high adherence rates. Clinicians need to know how their patients will respond to the drug in routine medical practice; potential effects of factors such as race, age, gender, comorbidities, work status and drug interactions.

The journal “Real-world data & evidence” (MyRWD) aims to provide a dissemination vehicle and forum for discussion of information about how drugs work in routine medical practice. The journal's rubrics include both original research and reviews of the use of real-world data to measure treatment outcomes, make informed health decisions about drugs, medical devices and other interventions.

“Real-world data & evidence” (MyRWD) gives you access to research on drug use, prescribing regimens, pharmacovigilance, adherence, benefit-risk assessment, comparative efficacy research and economic analysis.

The journal is published only on the Internet in two languages ​​(Russian and English), both in Adobe Acrobat (.pdf) and HTML-formats, and is completely have an open access to readers. The journal website http://MyRWD.ru constantly updates the news feed, to which it is recommended to subscribe.

The journal is intended for researchers, healthcare leaders, heads of departments, heads of clinical departments and teachers of medical educational institutions, employees of leading pharmaceutical companies.

 

Section Policies

FROM EDITOR-IN-CHIEF
Checked Open Submissions Checked Indexed Unchecked Peer Reviewed
ORIGINAL ARTICLES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
ACTUAL REVIEW
Checked Open Submissions Checked Indexed Checked Peer Reviewed
CLINICAL REGISTERS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PUBLIC PROCUREMENT
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DRUG UTILIZATION RESEARCH
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PRAGMATIC CLINICAL TRIALS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
LARGE SIMPLE TRIALS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
COHORT STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
NON-INTERVENTIONAL STUDIES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
COMPARATIVE EFFECTIVENESS RESEARCH
Checked Open Submissions Checked Indexed Checked Peer Reviewed
DRUG SAFETY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
HEALTH TECHNOLOGY ASSESSMENT
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PERSONALIZED THERAPY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PATIENT REPORTED OUTCOMES
Checked Open Submissions Checked Indexed Checked Peer Reviewed
RESEARCH METHODOLOGY
Checked Open Submissions Checked Indexed Checked Peer Reviewed
PRACTICAL RECOMMENDATIONS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
EXPERT OPINIONS
Checked Open Submissions Checked Indexed Checked Peer Reviewed
BOOKSHELF
Checked Open Submissions Checked Indexed Checked Peer Reviewed
RESOLUTION
Checked Open Submissions Checked Indexed Checked Peer Reviewed
 

Publication Frequency

The journal "Real-world data & evidence" - it is a system of online publications: articles published as they become available, with additions to the current volume table of contents. 
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.

 

Open Access Policy

"Real-world data & evidence" is an open access journal. All articles are made freely available to readers immediatly upon publication.

Our open access policy is in accordance with the Budapest Open Access Initiative (BOAI) definition - it means that articles have free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself.

For more information please read BOAI statement.

 

Archiving

  • Russian State Library (RSL)
  • National Electronic-Information Consortium (NEICON)
  • CyberLeninka
  • RSL Russian State Library

 

Peer-Review

  1. A bilateral anonymous ("blind") peer review method is mandatory for processing of all scientific manuscripts submitted to the editorial stuff of “Real-world data & evidence” (MyRWD). This implies that neither the reviewer is aware of the authorship of the manuscript, nor the author maintains any contact with the reviewer.
  2. Members of the editorial board and leading Russian experts in corresponding areas of life sciences, invited as independent readers, perform peer reviews. Editor-in-chief, deputy editor-in-chief or science editor choose readers for peer review. We aim to limit the review process to 2-4 weeks, though in some cases the schedule may be adjusted at the reviewer’s request.
  3. Reviewer has an option to abnegate the assessment should any conflict of interests arise that may affect perception or interpretation of the manuscript. Upon the scrutiny, the reviewer is expected to present the editorial board with one of the following recommendations:
    - to accept the paper in its present state;
    - to invited the author to revise their manuscript to address specific concerns before final decision is reached;
    - that final decision be reached following further reviewing by another specialist;
    - to reject the manuscript outright.
  4. If the reviewer has recommended any refinements, the editorial staff would suggest the author either to implement the corrections, or to dispute them reasonably. Authors are kindly required to limit their revision to 2 months and resubmit the adapted manuscript within this period for final evaluation.
  5. We politely request that the editor to be notified verbally or in writing should the author decide to refuse from publishing the manuscript. In case the author fails to do so within 3 months since receiving a copy of the initial review, the editorial board takes the manuscript off the register and notifies the author accordingly.
  6. If author and reviewers meet insoluble contradictions regarding revision of the manuscript, the editor-in-chief resolves the conflict by his own authority.
  7. The editorial board reaches final decision to reject a manuscript on the hearing according to reviewers’ recommendations, and duly notifies the authors of their decision via email. The board does not accept previously rejected manuscripts for re-evaluation.
  8. Upon the decision to accept the manuscript for publishing, the editorial staff notifies the authors of the scheduled date of publication.
  9. Kindly note that positive review does not guarantee the acceptance, as final decision in all cases lies with the editorial board. By his authority, editor-in-chief rules final solution of every conflict.
  10. Original reviews of submitted manuscripts remain deposited for 3 years.

 

Publishing Ethics

The Publication Ethics and Publication Malpractice Statement of the journal  “Real-world data & evidence” (MyRWD) are based on the Committee on Publication Ethics (COPE) Code of Conduct guidelines available at www.publicationethics.org .

  1. Introduction

1.1. The publication in a peer reviewed learned journal, serves many purposes outside of simple communication. It is a building block in the development of a coherent and respected network of knowledge. For all these reasons and more it is important to lay down standards of expected ethical behaviour by all parties involved in the act of publishing: the author, the journal editor, the peer reviewer, the publisher and the society for society-owned or sponsored journal: “Real-world data & evidence” (MyRWD).

1.2. Publisher has a supporting, investing and nurturing role in the scholarly communication process but is also ultimately responsible for ensuring that best practice is followed in its publications.

1.3. Publisher takes its duties of guardianship over the scholarly record extremely seriously. Our journal programs record «the minutes of science» and we recognize our responsibilities as the keeper of those «minutes» in all our policies not least the ethical guidelines that we have here adopted.

  1. Duties of Editors

2.1. Publication decision  The Editor of the journal  “Real-world data & evidence” (MyRWD) is solely and independently responsible for deciding which of the articles submitted to the journal should be published, often working on conjunction with the relevant society (for society-owned or sponsored journals). The validation of the work in question and its importance to researchers and readers must always underwrite such decisions. The Editor may be guided by the policies of the  “Real-world data & evidence” (MyRWD) journal’s editorial board and constrained by such legal requirements as shall then be in force regarding libel, copyright infringement and plagiarism. The editor may confer with other editors or reviewers (or society officers) in making this decision.

2.2. Fair play  An editor should evaluate manuscripts for their intellectual content without regard to race, gender, sexual orientation, religious belief, ethnic origin, citizenship, or political philosophy of the authors.

2.3. Confidentiality – The editor and any editorial staff of  “Real-world data & evidence” (MyRWD) must not disclose any information about a submitted manuscript to anyone other than the corresponding author, reviewers, potential reviewers, other editorial advisers, and the publisher, as appropriate.

2.4. Disclosure and Conflicts of interest

2.4.1. Unpublished materials disclosed in a submitted manuscript must not be used in an editor’s own research without the express written consent of the author. Privileged information or ideas obtained through peer review must be kept confidential and not used for personal advantage.

2.4.2. Editors should recuse themselves (i.e. should ask a co-editor, associate editor or other member of the editorial board instead to review and consider) from considering manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies, or (possibly) institutions connected to the papers.

2.5. Vigilance over published record  An editor presented with convincing evidence that the substance or conclusions of a published paper are erroneous should coordinate with the publisher (and/or society) to promote the prompt publication of a correction, retraction, expression of concern, or other note, as may be relevant.

2.6.Involvement and cooperation in investigations  An editor should take reasonably responsive measures when ethical complaints have been presented concerning a submitted manuscript or published paper, in conjunction with the publisher (or society). Such measures will generally include contacting the author of the manuscript or paper and giving due consideration of the respective complaint or claims made, but may also include further communications to the relevant institutions and research bodies.

  1. Duties of Reviewers

3.1. Contribution to Editorial Decisions – Peer review assists the editor in making editorial decisions and through the editorial communications with the author may also assist the author in improving the paper. Peer review is an essential component of formal scholarly communication, and lies at the heart of the scientific method. Publisher shares the view of many that all scholars who wish to contribute to publications have an obligation to do a fair share of reviewing.

3.2. Promptness – Any selected referee who feels unqualified to review the research reported in a manuscript or knows that its prompt review will be impossible should notify the editor of  “Real-world data & evidence” (MyRWD) and excuse himself from the review process.

3.3. Confidentiality – Any manuscripts received for review must be treated as confidential documents. They must not be shown to or discussed with others except as authorised by the editor.

3.4. Standard and objectivity – Reviews should be conducted objectively. Personal criticism of the author is inappropriate. Referees should express their views clearly with supporting arguments.

3.5. Acknowledgement of Sources – Reviewers should identify relevant published work that has not been cited by the authors. Any statement that an observation, derivation, or argument had been previously reported should be accompanied by the relevant citation. A reviewer should also call to the editor’s attention any substantial similarity or overlap between the manuscript under consideration and any other published paper of which they have personal knowledge.

3.6. Disclosure and Conflict of Interest

3.6.1. Unpublished materials disclosed in a submitted manuscript must not be used in a reviewer’s own research without the express written consent of the author. Privileged information or ideas obtained through peer review must be kept confidential and not used for personal advantage.

3.6.2. Reviewers should not consider manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies, or institutions connected to the papers.

  1. Duties of Authors

4.1. Reporting standards

4.1.1. Authors of reports of original research should present an accurate account of the work performed as well as an objective discussion of its significance. Underlying data should be represented accurately in the paper. A paper should contain sufficient detail and references to permit others to replicate the work. Fraudulent or knowingly inaccurate statements constitute unethical behaviour and are unacceptable.

4.1.2. Review and professional publication articles should also be accurate and objective, and editorial 'opinion’ works should be clearly identified as such.

4.2. Data Access and Retention – Authors may be asked to provide the raw data in connection with a paper for editorial review, and should be prepared to provide public access to such data (consistent with the ALPSP-STM Statement on Data and Databases), if practicable, and should in any event be prepared to retain such data for a reasonable time after publication.

4.3. Originality and Plagiarism

4.3.1. The authors should ensure that they have written entirely original works, and if the authors have used the work and/or words of others, this has been appropriately cited or quoted.

4.3.2. Plagiarism takes many forms, from ‘passing off’ another’s paper as the author’s own paper, to copying or paraphrasing substantial parts of another’s paper (without attribution), to claiming results from research conducted by others. Plagiarism in all its forms constitutes unethical publishing behaviour and is unacceptable.

4.4. Multiple, Redundant or Concurrent Publication

4.4.1. An author should not in general publish manuscripts describing essentially the same research in more than one journal of primary publication. Submitting the same manuscript to more than one journal concurrently constitutes unethical publishing behaviour and is unacceptable.

4.4.2. In general, an author should not submit for consideration in another journal a previously published paper.

4.4.3. Publication of some kinds of articles (eg, clinical guidelines, translations) in more than one journal is sometimes justifiable, provided certain conditions are met. The authors and editors of the journals concerned must agree to the secondary publication, which must reflect the same data and interpretation of the primary document. The primary reference must be cited in the secondary publication. Further detail on acceptable forms of secondary publication can be found at www.icmje.org.

4.5. Acknowledgement of Sources – Proper acknowledgment of the work of others must always be given. Authors should cite publications that have been influential in determining the nature of the reported work. Information obtained privately, as in conversation, correspondence, or discussion with third parties, must not be used or reported without explicit, written permission from the source. Information obtained in the course of confidential services, such as refereeing manuscripts or grant applications, must not be used without the explicit written permission of the author of the work involved in these services.

4.6. Authorship of the Paper

4.6.1. Authorship should be limited to those who have made a significant contribution to the conception, design, execution, or interpretation of the reported study. All those who have made significant contributions should be listed as co-authors. Where there are others who have participated in certain substantive aspects of the research project, they should be acknowledged or listed as contributors.

4.6.2. The corresponding author should ensure that all appropriate co-authors and no inappropriate co-authors are included on the paper, and that all co-authors have seen and approved the final version of the paper and have agreed to its submission for publication.

4.7. Hazards and Human or Animal Subjects

4.7.1. If the work involves chemicals, procedures or equipment that have any unusual hazards inherent in their use, the author must clearly identify these in the manuscript.

4.7.2. If the work involves the use of animal or human subjects, the author should ensure that the manuscript contains a statement that all procedures were performed in compliance with relevant laws and institutional guidelines and that the appropriate institutional committee(s) have approved them. Authors should include a statement in the manuscript that informed consent was obtained for experimentation with human subjects. The privacy rights of human subjects must always be observed.

4.8. Disclosure and Conflicts of Interest

4.8.1. All authors should disclose in their manuscript any financial or other substantive conflict of interest that might be construed to influence the results or interpretation of their manuscript. All sources of financial support for the project should be disclosed.

4.8.2. Examples of potential conflicts of interest which should be disclosed include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding. Potential conflicts of interest should be disclosed at the earliest possible stage.

4.9. Fundamental errors in published works – When an author discovers a significant error or inaccuracy in a published work, it is the author’s obligation to promptly notify the editor of  “Real-world data & evidence” (MyRWD) journal and cooperate with Publisher to retract or correct the paper, If the editor or the publisher learn from a third party that a published work contains a significant error, it is the obligation of the author to promptly retract or correct the paper.

  1. Duties of the Publisher (and if relevant, Society)

5.1. Publisher should adopt policies and procedures that support editors, reviewers and authors of  “Real-world data & evidence” (MyRWD) in performing their ethical duties under these ethics guidelines. The publisher should ensure that the potential for advertising or reprint revenue has no impact or influence on editorial decisions.

5.2. The publisher should support  “Real-world data & evidence” (MyRWD) journal editors in the review of complaints raised concerning ethical issues and help communications with other journals and/or publishers where this is useful to editors.

5.3. Publisher should develop codes of practice and inculcate industry standards for best practice on ethical matters, errors and retractions.

5.4. Publisher should provide specialized legal review and counsel if necessary.

 

Founder

LLC “Publishing House OKI”Association specialists in Health Technology Assessment

 

 

Author fees

In the journal “Real-world data & evidence" there is no fee for the publication of manuscripts of applicants for the scientific degree of Candidate of Science and Doctor of Science, and articles should not be of an advertising nature and contain trade names of drugs and medical devices.

 

Disclosure and Conflict of Interest

Unpublished materials disclosed in a submitted manuscript must not be used in a reviewer’s own research without the express written consent of the author. Privileged information or ideas obtained through peer review must be kept confidential and not used for personal advantage.

Reviewers should not consider manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies, or institutions connected to the papers.

 

Plagiarism detection

“Real-world data & evidence" use native russian-language plagiarism detection software Antiplagiat to screen the submissions. If plagiarism is identified, the COPE guidelines on plagiarism will be followed.

 

Preprint and postprint Policy

Prior to acceptance and publication in “Real-world data & evidence", authors may make their submissions available as preprints on personal or public websites.

As part of submission process, authors are required to confirm that the submission has not been previously published, nor has been submitted. After a manuscript has been published in Real-world data & evidence" we suggest that the link to the article on journal's website is used when the article is shared on personal or public websites.

Glossary (by SHERPA)

Preprint - In the context of Open Access, a preprint is a draft of an academic article or other publication before it has been submitted for peer-review or other quality assurance procedure as part of the publication process. Preprints cover initial and successive drafts of articles, working papers or draft conference papers.
 
Postprint - The final version of an academic article or other publication - after it has been peer-reviewed and revised into its final form by the author. As a general term this covers both the author's final version and the version as published, with formatting and copy-editing changes in place.

 

Revenue Sources

The publication of the journal is financed by the funds of the parent organization, at the expense of the publisher, publication of advertising materials, publication of reprints, article processment charges.

 

Advertising policy

The journals advertising policy is based on the recommendations of the World Association of Medical Editors (WAME) Recommendations on Publication Ethics Policies for Medical Journals and the Law of the Russian Federation "On Advertising".

  1. The journals of Publishing House OKI receive income from advertising, which creates a potential conflict of interest. In order to avoid the influence of this circumstance on the publication process, the decisions of the editorial office do not depend on the cost of advertising or the production of reprints. Advertisers and sponsors have no influence whatsoever on the decisions of editors and editorial boards, regardless of advertising terms or other agreements.
  2. All advertising materials are subject to approval by the Publishing House OKI staff, which reserves the right to reject or cancel the display of any advertising at any time.
  3. The functions and responsibilities of editors and advertising managers in the journals of the Publishing House OKI do not overlap.
  4. In scientific publications and on the websites of the journals LLC "Publishing House OKI" it is prohibited to deliberately place advertisements next to articles about the company or the product being advertised. Advertising content is formatted differently from scientific and editorial publications, so that the difference between them is obvious.
  5. "Publishing House OKI" LLC does not publish "advertising articles", materials from sponsors and / or advertisers must be clearly marked as advertising. If the materials have not been reviewed or the review process was significantly different from that adopted in this journal, this should be clearly indicated.
  6. All journals of Publishing House OKI LLC have the right to reject any advertisement that, in the opinion of the editors, is incompatible with its mission or does not correspond to the objectives of the journal / website of the journal or publishing house, and to stop the publication process of any previously approved advertisement. Advertisements are subject to agreement with the editors and other employees of Publishing House OKI LLC. No separate agreements can override this rule.
  7. After placing an advertisement on the journals website on the Internet, it can be removed at any time if the editor-in-chief or employees of Publishing House OKI require its removal.
  8. Advertising of the following categories of goods and services is prohibited:
  • alcohol;
  • tobacco;
  • edged weapons and firearms, ammunition, explosive substances and methods of their manufacture;
  • gambling and lotteries;
  • pornography or related content;
  • political and religious advertising;
  • information on the availability of "miracle" drugs or treatments;
  • ads that contain unsubstantiated claims about the health benefits of the advertised products;
  • advertising aimed at children.
  1. Advertisements must not be misleading and must be verifiable, must clearly identify the advertiser and the product or service offered. Distortion, exaggeration or extravagant language in advertising is not allowed. Advertising materials will not be accepted for publication if they appear obscene or offensive, or if they are personal, racial, ethnic, sexual or religious in nature.
  2. Advertising materials are accepted and published by Publishing House OKI, subject to guarantees from the advertising agency and the advertiser that they have the appropriate rights and permissions to publish all the advertising content submitted for consideration.
  3. By submitting advertising materials for consideration, the advertiser and the advertising agency, jointly and separately, agree to be liable (including material) for any claims against LLC "Publishing House OKI", its officials, agents and employees and to compensate for costs and losses, incurred as a result of the publication of the relevant advertisement, its content, including (including agreeing to act as defendants in charges of libel, violation of confidentiality, copyright infringement or plagiarism).
  4. Any mention of Publishing House OKI LLC, its products or services in advertising, promotional materials or goods by an advertiser or advertising agency requires the written permission of Publishing House OKI LLC.
  5. Advertising of medicines and medical services must comply with the requirements of Russian legislation. Advertisers must provide Publishing House OKI LLC with a sales permit and a brief description of the product's characteristics along with advertising materials. In the case of drug advertising, the proprietary names must be accompanied by the international non-proprietary or chemical names; the amount of all active substances should be indicated along with the recommended dosage. Each page of advertisements for prescription-only medicines should be clearly labeled as intended for healthcare professionals.
  6. Advertising of goods not registered on the territory of the Russian Federation, containing any statements about health benefits, must contain the following statement: “The information provided has not been verified and is not approved by the Ministry of Health opinion of the Russian Federation. This product is not intended to diagnose, treat, cure or prevent any disease. ”
  7. Although Publishing House OKI LLC welcomes the placement of advertisements with a large amount of textual content and data, advertisements should not look like scientific articles and peer-reviewed content; advertisers' banners and logos must be clearly distinguishable, and the advertising content itself may require special labeling. All advertising materials must clearly and unambiguously identify the advertiser by trademark and / or signature.
  8. Reprints should be published only in the form in which they were originally published in the journal (including subsequent corrections), therefore, they should not contain any additions or changes.
  9. Publishing House OKI LLC is not responsible for incidental or consequential damage due to errors in the display or printing of advertisements.
  10. Advertising published in the journal does not mean that the advertiser has sponsored the journal or has any influence on the authors of any article, the process of its review in the editorial office and the editorial decision on the possibility of publication in the journal / website.
  11. The full rules of any market research or promotion associated with a published advertisement must be reflected in that advertisement or made available by direct link.
  12. Publishing House OKI LLC does not use the following online advertising formats:
  • pop-ups and floating ads;
  • advertisements that collect personal information from visitors without their knowledge or permission;
  • advertisements that block reading of the pages of the journals website (in whole or in part) without the ability to hide advertising information or refuse to view it;
  • advertisements that redirect visitors to other sites without having to click on the relevant banner ad.
  1. The policy of Publishing House OKI LLC in relation to advertising is not exhaustive and can be changed at any time without prior notice.
  2. Publishing House OKI LLC cooperates with third-party advertising companies to display advertisements and / or collect certain information when visiting our website. These companies may use cookies or web beacons to collect non-personally identifiable information [not including your name, address, email address, or phone number] while you visit this website in order to serve ads on other websites that also may interest you.

________________________

To contact the publishing house regarding the placement of advertisements in the journal / on the website, please contact:

Tel. +7 (910) 400-88-87

E-mail: eva88@list.ru

to the general director of LLC "Publishing House OKI"

Afanasyeva Elena