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Clinical Trial Data Transparency Policy

Declaration

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. Therefore, we are issuing this transparency policy to show our commitment to enhancing the transparency of our clinical trial data as mentioned below.

Registration and Disclosure of the Synopses of our Clinical Trials

Shionogi registers and discloses the synopses of our clinical trials through the World Health Organization (WHO) International clinical trials registry platforms in compliance with applicable laws and regulations.

Links to Clinical Trial Registry Platforms
JAPIC
(in Japan)
https://www.clinicaltrials.jp/cti-user/common/Top.jsp
ClinicalTrials.gov
(in the United States)
http://ClinicalTrials.gov
EU Clinical Trial Register
(in Europe)
https://www.clinicaltrialsregister.eu/ctr-search/search

Shionogi will also show the summary of the clinical trial reports of its medicinal products that are submitted for regulatory approval on our website*. This policy will apply to medicinal products approved starting February 2019.

* The website will be available on March 2019

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 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 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).

** Portal site: cliniclstudydatarequest.com
Sponsor specific details including the anonymization standards are available on this site
(Our information on the portal site will be available on March 2019)

Publications

Shionogi is committed to publishing the results of all of its clinical trials, irrespective of the outcome of the trials, based on the “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature” and “Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP3)”. For new medicinal products, the manuscripts will be submitted to peer-reviewed journals within 18 months after the regulatory approval***. In the case of clinical trials conducted with already marketed medicinal products, Shionogi will attempt to submit the manuscripts within 18 months of the completion of the study.
Shionogi’s publication policy and practices are aligned with the International Committee of Medical Journal Editors (ICMJE) recommendations and GPP3.

*** In case the study results are of limited scientific or clinical value, posting results on a public Web site after completion of the study will be an option for disclosure.

(December 5, 2018)

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