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Shionogi

About The purpose of the Shionogi Group’s corporate activities is, as expressed in the opening of “The Company Policy of Shionogi”, to “supply the best possible medicine to protect the health and wellbeing of the patients we serve.” This eternal and unwavering corporate philosophy is our foundation which supports us and what we should achieve globally. To achieve and live by the Company Policy, we have formulated “Shionogi Group Code of Conduct”. Through activities based on “The Company Policy of Shionogi” and “Shionogi Group Code of Conduct”, Shionogi will continue to contribute to patients, physicians and other healthcare providers, shareholders and investors, and furthermore to society as a whole.

Shionogi believes that disclosure of appropriate information of clinical trials contributes to advancing scientific progress and improving public health, and ultimately helps patients and healthcare providers make informed clinical decisions.
How we share on the Vivli Platform Studies available for sharing will be listed and searchable on the Vivli platform. Data requestors should use the Vivli Data Request Form to request Shionogi data package(s).

If the request is approved, researchers will need to sign a Data Use Agreement. The anonymized data and redacted documents will be provided in a secure research environment on Vivli to further protect participant privacy.
Studies listed for sharing Shionogi will list clinical studies that were:

 

  • Shionogi sponsored Phase 1 to 4 interventional clinical studies in patients.
  • used as part of a regulatory approval of new medicine or new indication in Japan (JP), the United States (US), and European Union (EU) except for regions where the regulatory submissions are not planned.
Exceptions Clinical studies in following conditions will be excluded from the list:

 

  • When there is a reasonable likelihood that individuals could be re-identified (for example, studies of very rare diseases, single center studies, or studies with a very small number of patients.)
  • Studies in which clinical data were collected subject to legal, contractual or consent provisions that prohibit or limit transfer to third parties.
  • Where agreement to disclosure clinical data is not gained with a co-development/research/marketing/promotion partner for a product/medicine.
When Studies are available for sharing When the medicine and the indication have received the regulatory approval in JP, US and EU on December 5th 2018 or later, and the primary manuscript describing the results has been accepted for publication.
Additional Conditions for Access The access to clinical trial data may be limited or precluded in following cases:

 

  • Where the research purpose does not include the public health improvement
  • Where there is a potential conflict of interest or an actual/potential competitive risk.
  • When the research proposal competes with the Shionogi publication plan
  • Where there are any practical constraints to providing access to the data. (ex. issues related to size of databases)
  • When the costs to retrieve data and documents from archives or to redact personally identifiable information from relevant documents or datasets are considerable.
  • Where supporting documents are not in English.
What information will be provided Where available, the following anonymized patient level data and information is provided for each clinical study.

  • Raw dataset or SDTM datasets. 
  • Protocols with any amendments. 
  • Statistical analysis plan (SAP).
  • Dataset specifications.

Redactions to this document will also be made to protect personal data of study participants, study personnel, Shionogi employees, and to protect Shionogi’s commercially confidential information, including intellectual property rights.
Questions or enquiries Researchers can enquire about the availability of data from Shionogi clinical studies that are not listed on the site before they submit a research proposal.
Review Criteria for Data Requests
  • 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.
  • Whether the proposal has potential to produce information that will enable identification of individual research participants.
  • The publication plan for the research.
  • Any 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.
  • The qualifications and experience of the research team to conduct the proposed research review.
Data Request Review Process Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts.
Access to study documents without participant-level data    –
Anonymization Standards   Shionogi Data Anonymization Standards
Clinical Study Register or Website JAPIC (in Japan)
jRCT (in Japan)
ClinicalTrials.gov (in the United States)
EU Clinical Trial Register (in Europe)
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