|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).|
|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||Review Criteria for Data Requests The review criteria are:
– General (formal) assessment
– Patient’s perspective
– Scientific perspective
– Methodology assessmentDuring the review process, following items will be assessed:
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 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.|
|Clinical Study Register or Website||https://www.Lundbeck.com/trials|