|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’ 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).
|Studies Listed for Sharing||Daiichi Sankyo will list Phase 2, Phase 3 and Phase 4 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.|
|Exceptions|| • Studies where there is reasonable likelihood that patients’ anonymity cannot be maintained. For example in very rare diseases, studies with very low patient numbers or studies performed at a single center.
• When necessary to restrict information to protect commercially confidential information and intellectual property rights on rare occasions.
• Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical data will be excluded.
|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 anonymised 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 organisation 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. 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||• The primary manuscript of the study has been published or accepted for publication.
• Daiichi Sankyo must be able to provide the requested data. For example, some non-interventional (or observational) studies use data from third party databases under license agreements which prevent Daiichi Sankyo from providing access to the data. Researchers may seek access to data directly from these third party databases under similar agreements.
• Daiichi Sankyo must have the legal authority to provide the data. For example, Daiichi Sankyo may not have the legal authority because the medicine has been out-licensed to another company.
• Daiichi Sankyo must consider it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
• There must not be any considerable operational constraints (costs, resource) to providing access to the data.
|Data Request Review Process||• Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal.
• In exceptional circumstances, access to data may be declined by Daiichi Sankyo, for example, where there is a potential conflict of interest or an actual or potential competitive risk.
|Access to study documents without participant-level data||Daiichi Sankyo also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies) via the Vivli platform.|
|Anonymization Standards||Anonymization Standards|
|Clinical Study Register or Website||https://www.daiichisankyo.com/rd/our_approach/clinical_studies/result/index.html|