|About||Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com|
|How we share on the Vivli Platform||Completed studies that has reached global end or completion with all data set collected and analyzed are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data Request Form to request Daiichi Sankyo’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||Completed Daiichi Sankyo-sponsored interventional clinical studies in patients that form part of the submission package for medicines and indications with marketing authorization after 1 January 2014 in:
|When Studies are Available for sharing||Completed studies with full datasets will be listed after the medicine and indication supported have received US and EU, and/or Japan marketing approval as described above and after the primary manuscript describing the results have been accepted for publication, whichever is later.|
|Additional Conditions for Access||Access may be declined on rare occasions, for example, where there is a potential conflict of interest between Daiichi Sankyo and the requesting party, or an actual or potential competitive risk.
The external research request must not extend beyond the limitation of participants’ consent.
|What information will be provided||Where available and based on the request, access may be granted to qualified researchers the following anonymized/de-identified patient level data and redacted clinical trial documents for each clinical study:
🗹 Individual Patient Data (raw/SDTM). This is the data collected for each patient and used for analysis in the clinical study.
🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial and information about all amendments.
🗹 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.
🗹 Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
🗹 Clinical study report synopsis. 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 the Pharmaceuticals and Medical Device Agency (PMDA). Documents will be redacted to protect personal data of study participants, study personnel, and Daiichi Sankyo employees, and to protect Daiichi Sankyo’s commercially confidential information and intellectual property rights. Appendices which include patient level data are not included. Daiichi Sankyo will not share case narratives.
|Questions or enquiries||Researchers can enquire about the availability of data from Daiichi Sankyo clinical studies that are not listed on the site before they submit a research proposal. In addition, 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.|
|Review Criteria for Data Requests||
|Data Request Review Process||
|Access to study documents without participant-level data||Daiichi Sankyo may also accept enquiries for study level documents such as clinical study report Synopsis, Statistical Analysis Plan and Protocols -only access (consistent with the above data sharing policies) via the Vivli platform.
Additionally, published Clinical Document Packages per Health Canada’s Public Release of Clinical Information and European Medicines Agency’s Policy 0070 on the respective agency-controlled websites and databases may be accessed.
|Anonymization Standards||Anonymization Standards|
|Clinical Study Register or Website||https://www.daiichisankyo.com/rd/clinical_trials/list/|