Clinical Trial Data Transparency

Shionogi believes that disclosure of detailed information of clinical trials contributes to advancing scientific progress, improving public health, and ultimately helping patients and healthcare providers make informed clinical decisions.

Accordingly, researchers can request access to information regarding Shionogi’s clinical trials, including protocols of the trials and data of individual patients using the link below. Sharable information includes the data on Shionogi’s clinical trials conducted for patients in the United States, Japan, and Europe. The information will become available upon request after the medicinal products for which the trials are performed have been approved in all the regions in which Shionogi intends to gain approval. This policy applies to the medicinal products that will be approved after February 2019. Requests from researchers will be reviewed by an Independent Review Panel, consisting of third-party experts, with regard to the validity and feasibility of the research that the researchers intend to carry out. When the request is approved by the panel, the researchers will be requested to execute a contract (which will have certain requirements with respect to personal data privacy, confidentiality, and compliance with the law) with Shionogi before being provided with access to the clinical trial data. Individual patient data will be shared after additional anonymization in order to protect the privacy of study participants and to comply with applicable laws and regulations, as well as the patient informed consent forms.

Detailed information on Shionogi’s current development areas can be found at clinicaltrials.gov and clinicaltrialsregister.eu.  Further, Shionogi’s global Clinical Trial Data Transparency Policy can also be accessed using the link below.

Shionogi & Co., Ltd. Clinical Trial Data Transparency Policy