Policy for scientific publications and responsible clinical trial data sharing

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.    

Lundbeck publishes the results from clinical studies of its products and drug development candidates, irrespective of whether the results are positive or negative, and acknowledges a special obligation to publish data related to patient safety. 

Per current Good Publication Practice, Lundbeck will submit for publication the results of Lundbeck-sponsored clinical studies, primarily in peer-reviewed journals, or as abstracts, posters, or other presentations at scientific meetings. Lundbeck will publish through open access journals whenever possible.

Publication activities will be undertaken responsibly and ethically to ensure that all relevant information is communicated clearly and in a timely manner. Wherever possible, manuscripts will be submitted no later than 18 months after study completion for approved products. The commitment to publish also applies to drug development compounds for which development has been discontinued. In situations when the data are of limited scientific or clinical value, or in the case of multiple journal rejections, posting results on a public clinical trial registry site may be an option for disclosure. 

Lundbeck encourages publication of the results from drug discovery. The timing of nonclinical publications will take into consideration intellectual property rights as well as legislation and national practices in patent law.

When entering into research and development collaborations, it is Lundbeck’s commitment to maintain ethical and transparent publication practices, which is in accordance with Good Publication Practice.

Lundbeck will prepare clinical publications in accordance with the guidelines established by the International Committee of Medical Journal Editors (ICMJE). 

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.

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.
  

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.

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.

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

Lundbeck is committed to responsible sharing of clinical trial data in a manner that is consistent with: safeguarding the privacy of patients, respecting the integrity of national regulatory systems and protecting the intellectual property of the sponsor. 

As a pharmaceutical company, Lundbeck considers the sharing of information from company-sponsored clinical trials to be an important aspect of advancing research and thereby supporting our purpose of advancing brain health for the future benefit of patients. Lundbeck is committed to sharing clinical trial data from products and indications approved in Europe and/or the United States after January 1, 2014. Requests for other clinical trial data are assessed on a case-by-case basis. 

Qualified researchers seeking access to patient-level data from Lundbeck clinical trials can visit the Vivli portal to make a data access request.

All applications from researchers for access to data and information will be reviewed by the: Scientific Review Board (SRB) which is responsible for assessing and deciding upon applications from qualified and medical researchers for access to anonymized individual patient data (“IPD”) or redacted clinical study reports (CSR) from clinical trials sponsored by Lundbeck or development partner. The charter for the SRB can be downloaded here: 

• Eduard Vieta (chair), Professor of Psychiatry, Hospital Clinic at University of Barcelona, Spain
• Michael Thase, Professor of Psychiatry, Perelman School of Psychiatry of the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center. Director, Mood and Anxiety Disorders Treatment and Research Center, USA
• Per Kragh Andersen, Professor, University of Copenhagen Dept. of Public Health, Denmark 

Each member participates in a personal capacity and does not represent any organization or institution with which he or she may be affiliated.

In determining whether a specific request for access to data and clinical trial information shall be granted, the SRB will consider all relevant information, including:

• Text in the study's informed consent regarding sharing of information with others, availability of data and are other studies (IITs or alike) ongoing with the same objectives
• Data requested
• Hypothesis to be tested and the rationale for the proposed research
• Statistical analysis plan
• Publication and posting plan
• Qualifications and experience of applicant and identified researchers of interest, and any potential conflicts of interests
• Source of any research funding

Researchers are responsible for gaining any other approvals that are required for the research (for example, from Ethics Committees, Institutional Review Boards, relevant research institutions or funding bodies).

When the application is approved and following receipt of a signed Vivli Data Use Agreement, the requested data will be anonymized and then Lundbeck will grant access using the Vivli platform.

The Data Sharing Agreement requires that after the researcher has completed the research per the approved study proposal and analysis plan, the researcher will share results with Lundbeck and pursue publication of results.