Clinical Trial Data Sharing
Researchers can request access to detailed information of Shionogi’s clinical trials, including protocols of the trials and data of individual patients, on a portal site. Sharable information includes the data on Shionogi’s clinical trials conducted for patients in Japan, the United States, and Europe. The information will become sharable 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 the day of enactment of the “Clinical Trial Data Privacy Policy” (December 5th, 2018).
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 anonymization in order to protect the privacy of study participants and to comply with laws and regulations (including but not limited to the terms of the patient informed consent forms).