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Taiho

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).
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.
Anonymization Standards	Anonymization Standard: Taiho Policy for Anonymization of Clinical Trial All data will be de-identified to protect the privacy of the patients who participated in Taiho sponsored clinical trials, in accordance with Health Insurance Portability and Accountability Act.
Clinical Study Register or Website	ClinicalTrials.gov https://clinicaltrials.gov/ Japan Pharmaceutical Information Center https://www.clinicaltrials.jp

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