|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:
|Exceptions||Clinical studies in following conditions will be excluded from the list:
|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:
|What information will be provided||Where available, the following anonymized patient level data and information is provided for each clinical study.
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||
|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)
https://jrct.niph.go.jp/searchClinicalTrials.gov (in the United States)
http://ClinicalTrials.govEU Clinical Trial Register (in Europe)