Clinical Trial Data Transparency Policy

1. Shionogi’s Pledge

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. For this purpose, we are issuing this policy to show our commitment to enhancing the transparency of our 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 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 disclose the summary reports of clinical trials performed as part of the regulatory submissions package for medical products that received regulatory approval, and of those whose development was terminated, on our website. This policy applies to medical products approved on or after the day of enactment of this policy and products whose development was terminated on or after the day of enactment of this policy.

In addition, Shionogi will disclose plain language summaries of clinical trials conducted in patients by Shionogi beginning in April 2020 or later, on our website.

3. Clinical Trial Data Sharing with External Researchers

Researchers can request access to information of Shionogi’s clinical trials, including clinical trial protocols and data from the clinical trials through Shionogi’s 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 or were approved on or after the day of enactment of this policy. 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 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).

 

* Portal site: cliniclstudydatarequest.com
Sponsor-specific details including the anonymization standards are available on this site.

4. 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 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