Center for Global Research Data

Our Members

Takeda

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: 

  • US and EU approval. 
  • US or EU approval (when regulatory submissions in both regions are not planned). 
  • Japan approval (when US or EU regulatory submissions are not planned).

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. 

Exceptions
  • Takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of trial participants. This may affect small clinical trials of rare diseases or trials conducted in a very small, easily identifiable patient population, which will be reviewed on a case-by-case basis. Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed.  
  • Data will generally only be shared once a trial has completed and sufficient time has elapsed to complete analyses/reporting and pursue a publication from the final data analysis. Interim data from clinical trials will generally not be shared by default, although  efforts will be made to share such data in long-term, event-driven trials (such as oncology) after primary  publication/ within 2 years of the interim analysis completion. 
  • In rare cases, information may be restricted/proposals not progressed by Takeda in order to protect commercially confidential information (CCI) and intellectual property (IP) rights. 
  • Takeda Consumer Healthcare products will not be subject to data sharing. 
When Studies are Available for sharing
  • Clinical trials will generally be eligible for listing once the above criteria are met, time has elapsed to allow analysis of the data and reporting to occur, and the primary manuscript has been accepted for publication.  
  • Clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in Japan), new indications, combination products, or major formulation changes for products that received initial approval since 01 January 2005 will be eligible for listing after the corresponding regulatory approvals have been achieved. 
  • Takeda will regularly update this list to add trials meeting the criteria. For in-scope trials that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries. 
Additional Conditions for Access
  • Data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted and applicable legal requirements. In general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. For Takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data. 
  • Where data is subject to legal, contractual, or consent provisions that restrict transfer to third parties, data access may be precluded. 
  • Other practical constraints to providing access to the data may also preclude sharing. 
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 support@vivli.org 
Review Criteria for Data Requests
  • The Research Proposal is compatible with study informed consent. 
  • The data and studies are available to perform the analysis. 
  • The planned analysis can be conducted in the data access system.  
  • The scientific rationale and relevance of the proposed research to medical science or patient care. 
  • The ability of the proposed research plan (design, methods, and analysis) to meet the scientific objectives. This is a high-level review. 
  • The publication plan for the research. 
  • Real or potential conflicts of interest that may impact the planning, conduct, or interpretation of the research and proposals to manage these conflicts of interest. Such conflicts may relate to (but are not limited to) the research team, their institutions/ affiliations, or their relationships to independent review panel members and Vivli staff. 
  • The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).
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).  
Anonymization Standards  
Clinical Study Register or Website  www.TakedaClinicalTrials.com