Shionogi Group Clinical Trial Data Transparency Policy

1. Shionogi’s Pledge

Shionogi consists of Shionogi & Co., Ltd., Shionogi Inc., Shionogi B.V. and other group companies together and believes that appropriate disclosure of clinical trial information contributes to advancing scientific progress and improving public health, and ultimately helps patients and healthcare providers make informed clinical decisions. For this purpose, Shionogi issues this policy to enhance the transparency of its clinical trial data as mentioned below.

2. Disclosure of the Synopses of our Clinical Trials and Trial Results

Shionogi discloses the synopses and results of its clinical trials on the following publicly available clinical trial information registration site in compliance with applicable laws and regulations. In addition, Shionogi disclose on Shionogi website summaries of the clinical study reports used in the application for regulatory approval of Shionogi products approved since the establishment of this policy and/or the clinical trials of investigational drugs that have been discontinued.

Links to Clinical Trial Registry Platforms 

JAPIC Clinical Trials Information (JapicCTI)

(in Japan)

https://www.clinicaltrials.jp/cti-user/common/Top.jsp

Japan Registry of Clinical Trials (jRCT)

(in Japan)

https://jrct.niph.go.jp/search

ClinicalTrials.gov

(in USA)

http://www.clinicaltrials.gov

EU Clinical Trial Register

(in Europe)

https://www.clinicaltrialsregister.eu/ctr-search/search

Shionogi will also disclose plain language summaries of clinical trials conducted in patients by Shionogi beginning in April 2020 or later, on its website as Shionogi believes that it is important to disclose clinical trial results to the general public.

3. Clinical Trial Data Sharing with External Researchers

In case researchers request access to information of Shionogi’s clinical trials through the portal site, the validity of the research and the researchers’ eligibility in the request will be reviewed by an Independent Review Panel, consisting of third-party experts. When the request is approved by the panel, the researchers and Shionogi will enter into a contract (which will have certain requirements with respect to personal data privacy, confidentiality, and compliance with the law) before being provided with access to the clinical trial data sharing server. Individual patient data from clinical trials 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). The shared data are Shionogi's clinical trials in patients that have been used to apply for regulatory approval of products that have been approved in all regions among Japan, USA, and Europe where Shionogi sought approval since the establishment of this policy.

4. Publications

Shionogi is committed to publishing the results of all of its clinical trials regardless of the results in accordance with the "Joint Position on the Publication of Clinical Trial Results in 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 medicinal products on the market, Shionogi will submit the manuscripts within 18 months of the completion of the study.
Drafting and submission of Shionogi’s publication manuscripts 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.

 

 

Enacted on December 5th, 2018

Revised on June 15th, 2020

Revised on January 1st, 2022