Clinical Data Transparency

Information regarding clinical studies sponsored by Ipsen is publicly disclosed at the start of the study. Study information will include a description of the research plan, such as the objectives and design of the clinical study.

This information can be accessed on the United States (U.S.) Clinical Trials Registry (ClinicalTrials.gov), the European Union (EU) Clinical Trials Register (clinicaltrialsregister.eu), the EU Clinical Trials Portal (euclinicaltrials.eu) and the European Medical Association (EMA) Real-World Data (RWD) Catalogues (catalogues.ema.europa.eu).  Beyond the global trial registries, Ipsen also ensures the disclosure of study information to various national clinical study registries or databases, in compliance with local regulations and legislative requirements.

The results of clinical trials sponsored by Ipsen are shared with the public following trial completion or termination. The summaries of clinical trial results are typically published within a year following the end of the trial or shortly after the marketing authorization has been granted. The disclosed study results include summaries presented in a scientific tabular format and/or detailed scientific report summaries.

These results are accessible on the U.S. Clinical Trials Register (ClinicalTrials.gov), the EU Clinical Trials Register (clinicaltrialsregister.eu) or EU Clinical Trials Portal (euclinicaltrials.eu) and the RWD Catalogues (catalogues.ema.europa.eu). Beyond the global trial registries, Ipsen also ensures the disclosure of study results to various national clinical study registries or databases, in compliance with local regulations and legislative requirements.

Ipsen is committed to sharing anonymized clinical study data such as individual patient-data (IPD) and supporting documents with qualified scientific and medical researchers upon request. Ipsen is pleased to be member of the data sharing platform www.vivli.org. Available studies are listed on this platform. Ipsen will regularly update this list to add eligible studies. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board. Anonymized data will be shared with qualified researchers through Vivli’s platform upon approval of the research proposal and signature of a Data Use/Sharing Agreement.

Ipsen ensures timely disclosure of clinical data that support our regulatory applications.  Clinical data is provided in publicly accessible websites operated by the EMA (clinicaldata.ema.europa.eu) and Health Canada (clinical-information.canada.ca), in accordance with Policy 0070 and Public Release of Clinical Information (PRCI), respectively.

Ipsen also engages with regulatory authorities to facilitate access to documents (about Ipsen products) in their possession. This includes both clinical and non-clinical data, internal communications, assessment reports, meeting minutes, and more.

In all cases, information is shared in a way that maximizes data utility while also protecting the privacy of study participants and personnel.

At Ipsen, our commitment to transparency and accountability is reflected in our adherence to ethical reporting guidelines, ensuring that all results whether positive, negative, or inconclusive are made accessible to the public. Since 2019 Ipsen aims to publish our journal articles with open access. We declare funding sources, institutional ties, and potential conflicts of interest to maintain the integrity of our publications.

Ipsen has committed to providing simple lay/plain language summaries, that include study results, in accordance with new regulatory requirements and as part of an Ipsen initiative to address the growing demand for transparency. These summaries aim to make clinical study information accessible to everyone and to ultimately enhance communication between patients, caregivers, and healthcare professionals.

Summaries are typically published within a year following the end of the trial or shortly after the marketing authorization has been granted. The summaries are accessible on the EU Clinical Trials Portal (euclinicaltrials.eu), Ipsen’s official website (Ipsen.com) and alongside company-sponsored journal publications (subject to journal rules).