This document presents the guidelines to which Mundipharma Research Limited (“MR”) is committed regarding the publication of scientific, technical and biomedical research sponsored by MR (not including investigator-initiated trials), in collaboration with its Independent Associated Companies (“IACs”) and, if applicable, with any Licensing Partners.
These guidelines concern all external scientific publications, for example peer-reviewed journal papers, abstracts and presentations at scientific congresses, whereby the research undertaken is to be placed into the public domain. MR will comply with the respective guidelines, for example the International Committee of Medical Journal Editors’ (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.(1) We acknowledge our obligation to present the results of biomedical research and development on our medicinal products to patients, physicians, and the scientific community, whilst protecting our proprietary information and intellectual property rights. MR therefore aims to publish clinical data in a responsible and timely manner, in accordance with applicable laws, regulations, and guidelines, as may be amended from time to time. All publications from MR will be accurate, balanced, and objective, regardless of the outcome of the clinical study.
MR clinical trials are based on sound scientific principles, ethical integrity, and adhere to strict national and regional regulatory authority guidelines. Accordingly, all external publications must reflect the quality of excellence applied to our work in biomedical research, regardless of the type of publication and irrespective of where the data is to appear. All MR-sponsored publications must adhere to the principles described below and to the “Instructions to Authors” of the journal or congress where they are to be submitted. This is also to hold true for any collaborative work undertaken with IACs, Licensing Partners, Clinical Research Organisations, and external Medical Communication agencies. The results of non-clinical scientific research carried out by MR will also be published according to the principles outlined within this document and according to the international accepted guidelines.
MR commits to publishing the key primary and secondary results of our registered clinical studies of marketed products (2-4) in accordance with the Declaration of Helsinki (Clauses 35 and 36) (5) and Good Publication Practice (GPP3) guidelines (6), in collaboration with IACs and Licensing Partners, as appropriate. The primary publication will present methods and results associated with the primary study outcomes and safety data in the scientific literature. In addition, MR scientific communication may include secondary publications, such as literature reviews, secondary, exploratory, meta- and post hoc analyses related to our medicinal products.
We may also present our data at scientific congresses and symposia worldwide by means of abstracts and thematic posters, oral presentations, and ecommunications. Translated versions of such manuscripts and abstracts / presentations may also be submitted to regional journals and congresses, in accordance with the congress, journal, and ICMJE guidelines (i.e. the translations must be identical to the original publication with the translated document clearly cited). (1)
In order to produce high quality publications, MR frequently collaborates with investigators and external scientific advisors who may have also been involved in our clinical studies. We work to Legal- and Quality Assurance-approved Standard Operating Procedures (SOPs) and present all publications in accordance with both the GPP3 guidelines (6) and applicable reporting guidelines, such as the CONSORT Statement (7). Our focus is on ethical integrity, transparency and accuracy. The journals and congresses where publications appear are chosen as outlined in our internal Publication Process SOP. All publications are to fulfil target journal and congress guidelines.
MR ensures that the study electronic database is made available to regulatory authorities. We will provide all invited authors of publications with the necessary study data, for example the clinical study report, for analysis and inspection based on a formal agreement regarding ownership and confidentiality. If requested, MR will provide a copy of the study protocol to the journal at the time of submission, based on the understanding that any such documentation is confidential and the property of MR.
MR will identify and formally invite authors for each publication, who will be responsible for the manuscript, based on the authorship guidelines as specified by the ICMJE. (8) Accordingly, all invited authors, regardless of whether they are internal or external to MR, must have made “1. substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND 2. drafting the work or revising it critically for important intellectual content; AND 3. final approval of the version to be published; AND 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.” (8)
MR does not support guest or ghost authorship: “guests” are defined as persons named as authors on a publication but who have neither contributed to the publication or study nor fulfil the authorship criteria as set out by the ICMJE; “ghosts” are authors who have made a substantial contribution to both the clinical study and preparation of the publication but who are not named as authors. (6,8-10) The corresponding author (11) for manuscript submissions may be someone other than the lead or first author, depending on the individual journal guidelines. MR may use professional medical writers who offer both scientific and writing expertise, either employed by MR, the IACs, or an external medical communications agency, or who are freelancers. Their contribution to the preparation, organisation and coordination of a manuscript, poster, or other scientific presentation will be formally acknowledged in the publication. (6,9-12) Contributorship will be defined according to the specifications outlined by the target journal or congress. (12)
MR is committed to openness and transparency. Any conflicts of interest, such as financial or personal relationships, which may be perceived to bias contributing authors, will be explicitly declared by the authors, either within the publication or as part of the submission process as outlined in the journal and congress submission guidelines.
Authors invited to participate in the generation of an MR publication will adhere to the copyright agreement as specified by the congress or journal to which the abstract or manuscript is submitted.
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