|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.|
|How do we share data on the Vivli Platform||Available studies 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 and the anonymized data will be shared in the Vivli secure research environment.|
|Studies Listed for Sharing||We provide access to Lundbeck sponsored Phase I-IV interventional clinical studies in healthy volunteers and patients for products and indications approved in the United States and/or the European Union after January 1st, 2014.
Requests for other clinical trial data should be requested via the Vivli Enquiry form and will be assessed on a case-by-case basis.
|Exceptions||Clinical trial data cannot be shared if:
We do not share raw imaging files and/or exploratory biomarker data.
|When Studies are Available for sharing||Studies are listed 6 months after the studied medicine and indication have 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.|
|Additional Conditions for Access||None|
|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 study:
|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 have an impact on 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 the 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.|
|Anonymization Standards||A risk-based quantitative anonymization approach was chosen based on existing precedent for the release of clinical trial information for secondary purposes, and in consistence with guidance produced by health regulators and industry best practices provided by organizations such as PhUSE and TransCelerate.|
|Clinical Study Register or Website||Clinical data sharing (lundbeck.com)|