About | Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. |
How we share 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 company’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. |
Anonymization Standards | The following data protection procedures for personally identifiable information are performed by Astellas prior to data sharing:
More information can be found in the Astellas Data De-Identification Standards. |
Studies Listed for Sharing | Astellas sponsored Phase 1 to 4 interventional clinical studies with a medicinal product in patients which have been completed after January 2010 and have been conducted for products and indications which have been approved in any country. Approval must have been granted by the agencies of the main regions US, EU and Japan. If approval is sought in only one or two regions, approval must have been granted by those agencies. Clinical trials will also be listed for Astellas sponsored Phase 1-4 interventional clinical studies with a medicinal product in patients relating to terminated products. Terminated products are unapproved medicines for which clinical development is completely terminated on or after 01 January 2014. |
Exceptions |
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Questions or enquiries | Researchers can enquire about the availability of data from Astellas clinical studies that are not listed on the site before they submit a research proposal. Please submit an enquiry using the Vivli platform. |
When Studies are Listed | Once a product is approved for the given formulation in the given indication or the development is completely terminated and the results from the study have been accepted for publication or presented in the public domain, the study is eligible be listed. |
Review Criteria for Data Requests |
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Additional Conditions for Access | When patients agreed to take part in Astellas clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Astellas was researching. Further research must therefore relate to the medicine or disease that was researched in the original studies.
In rare cases, the limitations of the informed consent of study participants might not allow data sharing. In such cases, Astellas will try to address requests by providing summary data or otherwise. |
Data Request Review Process | Data requests are initially reviewed by Vivli and Astellas for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and are then reviewed by a fully independent review panel. |
What information will be provided | Where available, the following anonymized patient level data and information is provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in the clinical study. Analysis-ready dataset. This is the dataset Astellas used for analysis. Protocols with any amendments or addenda. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study. Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset. Statistical analysis plan. This describes methods of analysis and procedures for data handling that Astellas used for the 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), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included. Documents will be redacted to protect personal data of study participants, study personnel, and Astellas employees, and to protect Astellas’ commercially confidential information, including intellectual property rights. |
Access to study documents without participant-level data | Researchers can enquire about access to clinical study documents only (without patient level data, such as the Clinical Study Report) by completing the online enquiry form. |
Clinical Study Register or Website | Astellas currently registers all its interventional clinical studies in patients on ClinicalTrials.gov. Summary results are included on www.astellasclinicalstudyresults.com. |