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About Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy and immunology, and urology. Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. Taiho helps qualified researchers obtain patient-level clinical trial data while maintaining patient privacy. It uses the Vivli data sharing platform to benefit patients in the near future.
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 Taiho’s data package(s).
Anonymization Standards
The following data protection procedures for personally identifiable information are performed by TAIHO prior to data sharing:
Research subjects’ identification code numbers: Replaced by a new code number, consistently across all datasets to keep the patient-record relationship.
Site identification information: Removed or recorded.
Date of birth: Removed. Replaced with age at study entry. Ages greater than 89 are aggregated as ’90 or older’
Country: Removed or aggregation to continent in some cases.
Dates/Times related to study subject: Replacing all original dates relating to individual subjects with randomly generated offsets which are then applied to create ‘dummy dates’ or replacing them with a ‘study day’.
Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
More information can be found in Anonymization Standard: Taiho Policy for Anonymization of Clinical Trial.
Studies listed for sharing We provide access to anonymized, patient-level and study-level clinical trial data (analysis-ready data sets) and other information (such as protocols and statistical analysis plan) from Taiho sponsored clinical studies in patients. Taiho will share for commercially available new products, that are approved after January 15, 2018 in the United States, the European Union, or Japan, and are not part of an ongoing or planned regulatory submission.

To learn more about Taiho sharing of patient-level data with researchers, click here.

Exceptions Clinical trial data cannot be shared if:

  • The studies include rare diseases and/or have small sample sizes. This is because the anonymization of these data is more difficult to achieve.
  • The data is subject to legal, contractual or consent provisions that prevent further sharing of data.
  • The studies where data labels and/or supporting documents are not in English.
  • There are practical constraints to providing the data (for example, issues related to the format of the databases, the legal authority with other companies, and the highly confidential information of Taiho properties).
When Studies are available for sharing Clinical trial data are available if the following two conditions are achieved.

  • The medicine or the indication received marketing approval from regulatory authorities in the United States, the European Union, or Japan after January 15, 2018.
  • Twelve months after the manuscript was published.
Additional Conditions for Access In exceptional circumstances, access to data may be declined by the sponsor. For example, a potential conflict of interest, or a potential competitive risk.
What information will be provided We commit to sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored clinical trials in patients.

If available, the following data and documents will be provided for each clinical study:

  • Protocol
  • Blank case report form
  • Statistical analysis plan
  • Anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored clinical trials in patients
  • Meta-data which describes the dataset.
  • Summary of clinical study report
Questions or enquiries Researchers can enquire about the availability of data from Taiho clinical trials that are not listed on the site before they submit a research proposal. Please use the Vivli Enquiry form.
Review Criteria for Data Requests

Data requests are initially reviewed by Taiho.

In determining whether a specific request for access to data and clinical trial information shall be granted, Taiho shall consider all relevant information which researchers provide.

Data Request Review Process Data requests are initially reviewed by Vivli and Taiho for completeness and other parameters and are then reviewed by a fully independent review panel.
Access to study documents without participant-level data Researchers can enquire about access to clinical study documents only, as the summary of clinical study report without patient-level data, by completing the Vivli online enquiry form.
Clinical Study Register or Website ClinicalTrials.gov
Japan Pharmaceutical Information Center