Disclosure of Clinical Study Data

Registration of Clinical Study Information and Disclosure of Clinical Study Results and Clinical Study Data

Sumitomo Dainippon Pharma Co., Ltd. believes that it should appropriately disclose to relevant parties, including healthcare providers, patients and researchers, information about and results of clinical studies (clinical trials) sponsored by Sumitomo Dainippon Pharma, with the aim of providing greater transparency of such clinical study data and realizing the full value thereof for contributing to scientific advancement, promotion of innovation, and enhancement of public health. Based on this recognition, we consistently register information on clinical studies and appropriately disclose study results in compliance with relevant laws, regulatory requirements, and industry guidelines for each country. In addition to these measures, in April 2018, we began providing access to our clinical study data via the data disclosure portal site clinicalstudydatarequest.com. Through defined processes using this portal site, researchers from outside of the company can access and analyze the clinical study data, which has been anonymized to protect personal information in accordance with relevant laws and regulations.

Registration of Clinical Study Information and Summaries of Study Results

Sumitomo Dainippon Pharma registers and discloses information about clinical studies that it sponsors, and the summarized results thereof, in the following clinical trial information registration databases, which are publicly accessible.

United
States
Registration/
Results
U.S. National Library of Medicine Clinical Trials Database

https://www.clinicaltrials.gov

Europe Registration/
Results
EU Clinical Trials (EudraCT database)

https://www.clinicaltrialsregister.eu

Japan Registration/
Results
Japan Pharmaceutical Information Center Clinical Trials Database (Clinical Trial Information/JapicCTI)

http://www.clinicaltrials.jp/user/cteSearch_e.jsp

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Publication of Clinical Study Results

Sumitomo Dainippon Pharma seeks to have results from all phase 3 clinical studies and any clinical study results of significant medical importance on its sponsored studies presented and published, regardless of study or trial outcomes, at scientific meeting and in peer-reviewed journals.

Sharing Clinical Study Data with Researchers

In response to requests from researchers, Sumitomo Dainippon Pharma may allow access to clinical study data provided that such requests have been reviewed and approved by an independent review panel of experts. Before patient-level data on a clinical study is provided to any researcher, such data will be anonymized to protect the personal information of participants in the clinical study concerned, in compliance with relevant laws and regulations. Please click on the link below to request disclosure of anonymized clinical study data.

Inquiries

Please contact us if you have any inquiries relating to disclosure of clinical study information. Please note that we may not be able to respond depending on the nature of the inquiry.