|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:
|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:
During the review process, following items will be assessed:
|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)|