Policy for scientific publications and responsible clinical trial data sharing

Lundbeck publishes the results from our research and clinical trials 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 trials 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 trials, 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 trial 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 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 trial 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 biopharmaceutical 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 review the list of available trials and make a data access request. The Vivli enquiry form should also be used when requesting data not already listed on the Vivli portal. 

All data requests from researchers will first be reviewed by Lundbeck for completeness, feasibility, compliance with the trial informed consent form and partner agreements as well as for the ability to anonymize data. Data requests are passed on to the Vivli Independent Scientific Review Board (SRB) for merit scientific review in a next step.

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 by the Vivli SRB and a Vivli Data Use Agreement has been signed by Vivli and each data requester’s organization, the requested data will be anonymized (if not done previously) and made available in the secure Vivli research environment. The researcher will by default have access to the anonymized data in the cloud for one year, however, this time can be extended if requested.

The Data Use Agreement stipulates that: ‘data recipients are expected to make the analysis results publicly available in printed form, on the internet, or in a  presentation in a learned forum and the recipient shall use reasonable efforts to obtain public disclosure of the analysis results in a peer-reviewed journal’. Any publication must be submitted to Vivli, who will share with all data contributors, at least 30 days prior to submission of publication or public disclosure.  All data requests with published or publicly presented results are listed on the Vivli portal.