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About Lundbeck is a global pharmaceutical company that is tirelessly dedicated to restoring brain health, so every person can be their best. Lundbeck considers the sharing of information from company-sponsored clinical trials to be an important part of fulfilling this purpose.
Studies Listed for Sharing Lundbeck sponsored phase I-IV interventional clinical trials for products and indications approved in the United States and/or the European Union after January 1st, 2014, will be listed on Vivli.

Requests for data from other clinical trials should be requested via the enquiry form and will be assessed on a case-by-case basis.

When Studies are Listed Trials are listed 6 months after the studied medicine and/or indication has been approved by regulators in the US and/or EU and after the primary manuscript describing the results has been accepted for publication, whichever is later.
How do we share data on the Vivli Platform Trials fulfilling the above criteria are listed and searchable on the Vivli Platform under ‘H. Lundbeck A/S’. Data requestors should use the Vivli Data request form to request Lundbeck’s data package(s). If approved, requesters will need to sign a Data Use Agreement before the anonymized data is made available in the Vivli secure research environment.
Exceptions Clinical trial data cannot be shared if:

  • the data is subject to legal, contractual or consent provisions that prevent further sharing of data
  • there are practical constraints to providing the data (for example, issues related to the format of the databases)
  • the study information is not in English
  • a significant proportion of participants must be removed due to national regulations
  • there is an actual or potential conflict of interest related to the data or the requester such as requests for competitive, commercial, or legal purposes
  • there is a reasonable likelihood that a participants could be re-identified (for example, clinical trials with a very small number of participants)

We do not share raw imaging files and/or exploratory biomarker data.

What information will be provided We provide access to anonymized, patient-level and study-level clinical trial data (analysis data sets) and study documents. If available, the following data and documents will be provided for each clinical trial:

  • Anonymized Individual Participant Data (IPD)
  • Full redacted protocol including amendments
  • Redacted Statistical Analysis Plan
  • Data Dictionary/define file
  • Redacted annotated electronic Case Report Forms (eCRFs)
  • Anonymization report
Anonymization Standards  
A risk-based quantitative approach is used to anonymize the Individual Participant Data (IPD) before it is shared via Vivli. This approach is consistent with guidance produced by health regulators and industry best practices provided by organizations such as PHUSE and TransCelerate.

BE AWARE! During the data anonymization process some variables in the datasets might be removed or transformed, which can impact analyses of the data. It is therefore of outmost importance that requesters check the supporting documents uploaded on Vivli for each trial to understand which changes have been made before data is requested. Although the anonymization strategy is trial-specific a few general rules are applied:

  • Participant ID: replaced (masked) by a new ID but is kept consistent across files within a trial (including extension trials).
  • Further unique IDs: Removed (suppressed)
  • Date of birth: Changed to age. Ages are often aggregated into 5–15-year groups, but for studies in children we keep unaggregated if at all possible.
  • Height/Weight: One or both is often removed (suppressed), but we keep weight if possible.
  • Dates: PHUSE shifted. This means dates are shifted by a number of days. The same shift is used across dates for a participant, however different shifts are used for different participants.
  • Free text fields (comments, initials): Removed (suppressed).

Lundbeck is proactively anonymizing IPD from listed phase III and IV trials, whereas IPD from phase I and II trials are only anonymized upon request. The data delivery timeline will therefore be longer if trials are requested that have not yet been anonymized.

Documents will be redacted to protect personal data of trial participants, study personnel, Lundbeck employees, and to protect Lundbeck’s commercially confidential information.

Questions or enquiries Researchers can enquire about the availability of data from Lundbeck clinical studies that are not listed on the site before they submit a research proposal. Please use the Vivli Enquiry form.
Review Criteria for Data Requests In addition to taking the exceptions listed above into account, the following review criteria are considered during the review process:

  1. Scientific objective: The research proposal must contain a research plan that explains the scientific rationale for the analysis and its relevance to medical research and/or patient outcomes.
  2. Study design: The analytical methods and statistical analysis plan must be valid and support the proposed research in a coherent way with the ability to meet the scientific objectives.
  3. Publication plan: The research proposal must contain a proposal for a publication plan demonstrating that the researcher/research group intends to publish the results of the study in a peer-reviewed scientific journal or otherwise make the results publicly available.
  4. Qualifications of the researchers: The researcher/research group must be qualified to perform the described analysis/study. The names and qualifications of all members of the research group must be included in the proposal. At least one statistician (degree in statistics or a related discipline) shall be designated as part of the research group.
  5. Conflicts of interest: Any real or potential conflicts of interest must be disclosed, as this could impact the conduct or interpretation of the research.
Data Request Review Process To request access to patient-level data, researchers should submit a scientifically valid research proposal via the Vivli platform. The request will undergo a Lundbeck subject matter expert review to ensure consistency with Lundbeck policy and partner agreements, ensure the analyses are consistent with the informed consent form(s) and that the research proposal does not conflict with ongoing Lundbeck analyses or publication plans. The scientific merit will be reviewed by the Vivli Independent Review Panel.
Access to study documents without participant-level data Lundbeck provides open access via our website to clinical trial result summaries (synopses) from Lundbeck-sponsored phase II-IV trials completed after January 1, 2014, following market authorization in US or EU.
Clinical Study Register or Website Clinical data sharing (lundbeck.com)