|About||Daiichi Sankyo is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the company’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.|
|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 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||Daiichi Sankyo-sponsored interventional clinical studies in patients that form part of the submission package for medicines and indications approved in the United States (U.S.), the European Union (EU), and/or Japan (JP), after 1 January 2014.|
|When Studies are Available for sharing||Studies are listed after the medicine and indication have received EU, U.S., and/or JP marketing approval, on or after 1 January 2014, and after the results from the studies have been accepted for publication.|
|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, the following anonymized patient level data and information is provided for each clinical study.
🗹 Raw dataset. This is the data collected for each patient in the clinical study.
🗹 Analysis-ready dataset. This is the dataset used for Daiichi Sankyo’s analysis.
🗹 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, via published clinical document packages per Health Canada’s Public Release of Clinical Information (PRCI) and EMA’s Policy 0070 on agency-controlled websites and databases.
|Anonymization Standards||Anonymization Standards|
|Clinical Study Register or Website||https://www.daiichisankyo.com/rd/clinical_trials/list/|