Lundbeck

About	Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. As a pharmaceutical company, Lundbeck considers the sharing of information from company-sponsored clinical trials to be an important part of fulfilling our mission.
How do we share data on the Vivli Platform	Available studies are listed and searchable on the Vivli Platform. 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 are assessed on a case-by-case basis.
Exceptions	Clinical trial data cannot be shared if: there is a reasonable likelihood that a patient could be re-identified 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
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 information such as protocols and clinical study reports.
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	The review criteria are: General (formal) assessment Patient’s perspective Scientific perspective Methodology assessment During the review process, following items will be assessed: 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. 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. 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. 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. 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 and whether the research proposal conflicts with ongoing Lundbeck analyses or publication plans. An independent Scientific Review Board is responsible for assessing and approval.
Access to study documents without participant-level data	Access to study documents without participant-level data will be made available via secure download from the Vivli platform.
Anonymization Standards	A risk-based anonymization approach was chosen based on existing precedents for the release of clinical trial information for secondary purposes, and in consistence with guidance produced by health regulators in support of clinical trials transparency. The methodology used for risk measurement and anonymization satisfies contemporary criteria for anonymization methodologies, is consistent with available guidance from regulators, and has been publicly documented and peer-reviewed. It is also consistent with other standards and guidelines for clinical trial data anonymization
Clinical Study Register or Website	Clinical data sharing (lundbeck.com)

Back to Our Members