|About||Takeda’s commitment to responsible data sharing reflects our strong commitment to our core values of integrity and transparency. Takeda is proud to 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 patient privacy and preserve the integrity of Takeda research.|
|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 Takeda’s data package(s).
|Studies Listed for Sharing||Clinical trials will be listed for Takeda-sponsored Phase 1-4 interventional trials supporting approved products as described below.
Commercially available new medicines or vaccines products that have received initial marketing approval since 01 January 2005 as follows:
Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional trials relating to terminated compounds. Terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 January 2014.
|When Studies are Available for sharing||
|Additional Conditions for Access||
|What information will be provided||Where available, the following anonymized patient level data and/or supporting documents are provided for each clinical trial. Information/ documents will not be translated and in rare instances, practical issues relating to redaction and availability of non-English documents may limit sharing. Best efforts will be made to anonymize data-sets and documents to reduce the risk of participant reidentification to near-zero. In addition, data and documents will be shared under agreements that further protect against participant reidentification and data are provided in a secure research environment further protecting participant privacy.
🗹 Raw dataset. This is the data collected for each patient in the clinical trial.
🗹 Analysis-ready dataset. This is the dataset used for Takeda’s analysis.
🗹 Protocols. 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.
🗹 Reporting and analysis plan. This describes statistical analysis plans that include methods of analysis, procedures for data handling, and data displays (figures and tables) that Takeda used for the trial.
🗹 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 trial. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient-level data are generally not included as these data are found in the datasets Takeda provides.
Documents will be redacted to protect personal data of trial participants, trial personnel, and Takeda employees (consistent with applicable privacy laws/regulations), and to protect Takeda’s CCI and IP rights when required. Takeda will generally not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI scans), genetic data, or other information that Takeda considers may compromise trial participant privacy.
|Questions or enquiries||Takeda accepts enquiries regarding the availability of patient-level data from clinical trials that are not yet listed on this site but that may be within the scope of Takeda’s data sharing policies. To enquire, please contact email@example.com.|
|Review Criteria for Data Requests||
|Data Request Review Process||Data requests are initially reviewed by Vivli and Takeda for completeness and other parameters (relating to scope, system-compatibility, and meeting sponsor policies) and are then reviewed by a fully independent review panel in a process that is managed by the Wellcome Trust.|
|Access to study documents without participant-level data||Takeda also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies).|
|Clinical Study Register or Website||www.TakedaClinicalTrials.com|