|About||Mitsubishi Tanabe Pharma contributes to the progress of medical science and medical treatment by increasing transparency in clinical trial information, clinical trial results, and clinical trial data, from clinical trials conducted by the MTPC group in a timely and appropriate manner. For clinical trials data sharing, Mitsubishi Tanabe Pharma will accept research requests from qualified researchers for patient-level clinical trial data using the Vivli data sharing platform to benefit patients and fosters scientific discovery in ways that maintain patients privacy and preserve the integrity of Mitsubishi Tanabe Pharma research.|
|How we share on the Vivli Platform||Qualified researchers can submit a proposal for access to anonymized patient level data from a Mitsubishi Tanabe Pharma-sponsored clinical trial using the Vivli Data Request Form. Mitsubishi Tanabe Pharma will use the Vivli platform to share anonymized data with approved researchers.|
|Studies Listed for Sharing||Mitsubishi Tanabe Pharma will list Phase 2, Phase 3 and Phase 4 Mitsubishi Tanabe Pharma sponsored interventional clinical studies conducted in patients that from part of the submission package for products and indications initially approved in the United States (U.S.), the European Union (EU)* and Japan (JP), in and after January 2018. Except for studies in healthy subjects other than vaccine studies.
* including European Economic Area; EEA
|When Studies are Available for Sharing||Studies are listed after the product and indication have initially received EU, the U.S., and JP marketing approval, in or after January 2018, and after the results from the studies have been accepted for publication.|
|Additional Conditions for Access||Access may be declined on occasions where, for example, there is a potential conflict of interest between Mitsubishi Tanabe Pharma and the requesting party, or an actual or potential competitive risk.
The external research request must not extend beyond the limitation of participants’ informed consent.
|What information will be provided||Where available, the following anonymized patient level data and information is provided for each clinical study:
🗹 De-identified Individual Patient Data (SDTM/ADaM dataset) This is the data collected for each patient in the clinical study.
🗹 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 Mitsubishi Tanabe Pharma employees, and to protect Mitsubishi Tanabe Pharma’s commercially confidential information and intellectual property rights. Appendices which include patient level data are not included. Mitsubishi Tanabe Pharma will not share case narratives.
|Questions or enquiries||Researchers can enquire about the availability of data from Mitsubishi Tanabe Pharma 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||Mitsubishi Tanabe Pharma also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies) .|
|Anonymization Standards||Mitsubishi Tanabe Pharma Anonymization Standards|
|Clinical Study Register or Website||https://www.mt-pharma.co.jp/e/|