SHIONOGI Group Publication Policy

SHIONOGI Group consists of Shionogi & Co., Ltd., Shionogi Inc., Shionogi B.V., and other affiliated companies. SHIONOGI Group believes that the appropriate disclosure of clinical trial data and other research findings contributes to advancing scientific progress and improving public health. This ultimately helps patients and healthcare providers make informed decisions. For this purpose, SHIONOGI Group issues this policy to enhance the transparency of its publications (i.e., journal manuscripts and presentations at scientific congresses) as described below.

SHIONOGI Group declares this policy to implement publications in accordance with the following:

This policy applies to all SHIONOGI Group directors and employees, contractors and/or consultants working on behalf of SHIONOGI Group. Publications covered by this policy include scientific publications based on SHIONOGI Group-sponsored clinical studies or health economic and epidemiological studies conducted by SHIONOGI Group, or non-clinical research with scientific value that receive support from SHIONOGI Group, as well as review articles that relate to SHIONOGI Group investigational and marketed products and those that receive support from SHIONOGI Group.

Research published by peer-reviewed journals undergoes rigorous review for scientific validity, quality, and originality and is a credible and robust way for SHIONOGI Group to communicate the latest research on its investigational and marketed products. We submit the results of our clinical research for publication in peer-reviewed journals so that the medical/scientific community and policymakers can make informed decisions for the betterment of human health.

We have developed and follow SHIONOGI's standard operating procedures for publication plan and execution to ensure that stakeholders involved in the publication process consistently produce publications in an ethical, transparent, and responsible manner. These standard operating procedures are adopted from and are applied in conjunction with those from the latest versions of ICMJE recommendations (Ref.1), GPP guidelines (Ref.2), and the individual journal or congress requirements. 

SHIONOGI Group is committed to publishing the results of all of its clinical trials regardless of the results in accordance with the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (Ref.3) and GPP (Ref.2).

For investigational medicinal products, the manuscripts will be submitted to peer-reviewed journals within 12 months after the regulatory approval*. In the case of clinical trials conducted with medicinal products on the market, SHIONOGI Group will submit the manuscripts within 18 months of the completion of the study*.

* Where study results are of limited scientific or clinical value, these may not be considered priority and/or be accepted by journals. SHIONOGI will make an independent assessment as to the scientific and clinical value of study results in each instance, and where it finds the study results are of limited value SHIONOGI may opt to  post results on a public website after completion of the study instead of publication in peer-reviewed journals.

Authors are identified early in the publication planning process, before any writing commences, and they are never compensated monetarily for the preparation or review of manuscripts.

All authors on SHIONOGI Group-sponsored publications shall meet all four of the ICMJE authorship criteria (Ref.1);

1. 1.  Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
2. 2.  Drafting the work or reviewing it critically for important intellectual content; AND
3. 3.  Final approval of the version to be published; AND
4. 4.  Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Individuals or groups who have contributed materially to a publication but meet fewer than all four of the above authorship criteria will not be listed as authors, but will be acknowledged as non-author contributors either as individuals or under headings such as “clinical investigators” or “participating investigators”.

Evidence suggests that the use of professional medical writers enhances publication quality and speed, and such assistance has been associated with a reduced risk for retractions due to misconduct (Ref.4).

As per industry standard, SHIONOGI group works with internal and external medical writers to help with manuscript development, including drafting and editing the publication under the authors’ direction and providing administrative support as needed. Authors retain full control over the publication content and decisions associated with publishing, such as journal or congress selection. Details of any medical writing support and any funding source are clearly acknowledged in the acknowledgements section of the publication. 

Commercial colleagues (with the exception of value access colleagues who are involved in designing and conducting research related to health economics and real-world data), are not involved in funding, planning, preparing or developing content for publications. However, as company scientific publications provide sources for marketing communications and other promotional materials, support product positioning and determine the overall marketing plan, the commercial organization may participate in the publications planning process whereby they are limited to high-level strategic input only. In any circumstance where an input has been provided regarding publications, a non-commercial function (e.g., Medical Affairs) will make the final decision from a medical/scientific point of view, including whether to accept or reject the suggestion. 

SHIONOGI Group discloses the following information in the publications.

Intellectual property (IP) is one of SHIONOGI Group’s most valuable resources, and its protection is key to future innovation and success. SHIONOGI Group protects its IP rights by completing mandatory reviews of publications. Publications may need to be delayed in order to protect SHIONOGI Group IP as advised by the SHIONOGI Group IP team in each instance. 

SHIONOGI Group enhance the transparency of its clinical trial data per SHIONOGI Group Clinical Trial Data Transparency Policy.

1.  International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. Published 2022. Accessed October 31, 2022. https://www.icmje.org/recommendations/

2.  DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research : 2022 Update. Ann Intern Med. 2022;175(9):1298-1304. doi:10.7326/M22-1460

3.  IFPMA, EFPIA, JPMA, PhRMA. Joint position on the publication of clinical trial results in the scientific literature. 2010. Available from: https://www.jpma.or.jp/basis/rinsyo/lofurc0000001vrn-att/100610_shishin_e.pdf

4.  AMWA-EMWA-ISMPP joint position statement on medical publications, preprints, and peer review. Curr Med Res Opin. 2021;37(5):861-866. doi:10.1080/03007995.2021.1900365

Effective date:  Janualy 22nd, 2024