|About||Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in oncology, rare disease and neuroscience.
Ipsen is committed to delivering on the principles of clinical trial transparency as set out in the joint European Federation of Pharmaceutical Industries and Associations (EFPIA) – Pharmaceutical Research and Manufacturers of America (PhRMA) principles for responsible clinical trial data sharing.
|How we share on the Vivli Platform||Studies available for sharing are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request Ipsen data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in Vivli secure research environment.|
|Studies Listed for Sharing||Completed Phase II to IV interventional studies from product with approved indications in the US and EU (US or EU when regulatory submissions in both regions are not planned):
Available studies are listed on the Vivli platform. Ipsen will regularly update this list to add eligible studies.
|Exceptions||Ipsen is unable to share clinical study data if:
For products where Ipsen has a co-research, co-development or co-marketing/co-promotion agreement, the responsibility for data sharing is dependent on the agreement between parties.
|When Studies are available for sharing||Data are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.|
|Additional Conditions for Access||When patients agreed to take part in Ipsen-sponsored clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Ipsen was researching. Further research must therefore relate to the medicine and/or disease that was researched in the original studies.
Only requests for non-commercial purposes will be considered.
|What information will be provided||Where available, the following anonymised patient level data and information is provided for each clinical study:
Some data may not be provided (e.g., exploratory biomarker data, images, electrocardiogram, pharmacokinetics data).
|Questions or enquiries||DataSharing@ipsen.com|
|Review Criteria for Data Requests||Ipsen will conduct a feasibility assessment for all enquiries received, based upon the criteria described below:
|Data Request Review Process||Researchers can request access to the listed studies by providing a research proposal with a commitment to publish their findings.
Data requests are initially reviewed by Vivli and Ipsen for completeness and feasibility and are then reviewed by an independent review panel.
|Access to study documents without participant-level data||Access to the Clinical Protocol and Clinical Study Report may be provided without participant-level data, upon approval of the research proposal and execution of the Data Use Agreement.|
|Anonymization Standards||Prior to sharing, clinical trial data is anonymized in accordance with data privacy laws, regulatory guidance, and best practices provided by organizations such as PhUSE.|
|Clinical Study Register or Website||Ipsen registers company-sponsored interventional clinical trials evaluating safety and/or efficacy on clinical trial registries, such as ClinicalTrials.gov and the European Clinical Trials Database (EudraCT), in compliance with applicable laws and regulations.|