Policy for scientific publications and responsible clinical trial data sharing

Lundbeck’s mission is to improve the quality of life of people suffering from psychiatric and neurological disorders. As a pharmaceutical company, Lundbeck considers the sharing of information from company-sponsored clinical trials to be an important part of fulfilling this mission. Lundbeck publishes the results from our research and clinical studies in scientific journals and presents these results at scientific conferences. Lundbeck also discloses clinical trial information and results summaries in public registries and shares clinical data. The Lundbeck policy for scientific publications and responsible clinical trial data sharing covers all scientific publications authored by Lundbeck and clinical trial data sharing for trials sponsored by H. Lundbeck A/S.

Overview

Lundbeck will prepare clinical publications in accordance with the guidelines established by the International Committee of Medical Journal Editors (ICMJE) and published in its “Uniform Requirements of Manuscripts Submitted to Biomedical Journals” (www.icmje.org). In addition, Lundbeck strives to follow the “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature” that was agreed by IFPMA, EFPIA, JPMA, and PhRMA.

Access to data for external authors 

 To protect intellectual property rights, any collaboration between Lundbeck and a third party will be subject to a formal agreement that will address ownership of and access to data. All authors of a Lundbeck-sponsored publication will be provided with a copy of the final protocol, statistical analysis plan, and clinical study report, including the statistical tables and figures that are needed to prepare the planned publication and, on request, will be provided access to the clinical study data.

Authorship

 Lundbeck is committed to ensuring that authorship for all publications complies with the criteria developed by the ICMJE. Lundbeck bases authorship credit on the following criteria:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • 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.

Contributions from persons who did not qualify as authors will be acknowledged.

Use of professional writers

 Lundbeck may employ professional writers to assist in producing publications and presentations. Care will be taken to ensure any such assistance follows ethically acceptable practice by ensuring that:

  • The authors approve the general content and direction of the manuscript before it is written.
  • There is no attempt to influence the opinions of the authors.
  • All the authors approve the final version of the manuscript before the primary author submits the manuscript to a journal, and thereby retain full responsibility for its content.
  • The assistance of the professional writer is acknowledged in the publication in line with his/her level of contribution.

Financial disclosure

 Lundbeck supports the need for all authors of publications to disclose any potential conflicts of interest, including any financial relationships that might be perceived to bias their work.

Honoraria

 Authors are not paid for authorship, but material support, for example professional medical writing assistance may be offered.

Confidentiality

Lundbeck respects the privacy of the relationship between patients and healthcare professionals and is committed to ensuring that the process of scientific publication and clinical trial data sharing do not breach patient confidentiality.

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