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Ipsen

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):

  • with a first patient enrolled as of 01Jan2005 onwards
  • where Ipsen is the marketing authorization holder

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:

  • the informed consent specifically does not allow to share de-identified data with a third party for secondary research,
  • there is a potential conflict of interest or an actual or potential competitive risk,
  • the data cannot be readily anonymised,
  • there is a reasonable likelihood that a patient could be re-identified (e.g., rare indication, monocentric studies, genetic/genomic data),
  • the data is subject to legal, contractual or data protection limitations that prevent sharing,
  • there are substantial practical constraints to providing the data,

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:

  • Patient-level clinical study data, this is the dataset collected for each patient in the clinical study.
  • Analysis-ready dataset, this is the dataset used for analysis.

Some data may not be provided (e.g., exploratory biomarker data, images, electrocardiogram, pharmacokinetics data).

  • Protocols with any amendments, this describes the objective(s), design, methodology, statistical considerations, and organization of a clinical study.
  • Annotated Case Report Form (CRF), this is a blank CRF that have been annotated with the dataset variable names.
  • Statistical Analysis Plan, this describes methods of analysis and procedures for data handling that were used for the clinical study report.
  • Dataset specifications, this is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
  • Clinical study report, this is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Questions or enquiries Researchers can enquire about the availability of data from clinical studies that are not listed on the site before they submit a data request. Please use the Vivli Enquiry form.
Review Criteria for Data Requests Ipsen will conduct a feasibility assessment for all enquiries received, based upon the criteria described below:

  • Whether the studies have been included in a completed regulatory filing (EU and US, US or EU when regulatory submissions in both regions are not planned).
  • Whether Ipsen has the legal authority to provide the data. For example, Ipsen may not have the legal authority because the medicine has been out-licensed to another company.
  • Whether Ipsen considers it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
  • Whether Ipsen considers that there are any practical constraints to providing access to the data, for example imaging data.
  • The resources (costs) for Ipsen to retrieve data and documents from repositories and archives, anonymize data, and redact personally identifiable information from relevant documents. In some cases, the costs could be considerable and Ipsen may turn down requests on this basis.
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.
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