Policy for the Disclosure of Clinical Study Data

Sharing of Clinical Study Data

Ono Pharmaceutical Co., Ltd. (Ono) believes that sharing clinical study data with researchers contributes to the promotion of scientific studies and medical research, thereby leading to public benefits. Ono shares clinical study data in accordance with the guidelines stipulated in the “IFPMA Principles for Responsible Clinical Trial Data Sharing” presented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) dated January 15, 2018, as well as in compliance with applicable laws, regulations and industry guidelines.

Disclosure of Clinical Study Protocols and Results

Ono discloses protocols for our sponsored clinical studies in patients in clinical study databases that are available to the public. For any of our products that have been approved for marketing or additional indications in Japan or outside Japan since January 1, 2014, Ono registers and discloses summaries of the clinical study results that Ono has utilized for our new drug applications (NDAs) in the clinical study databases. Ono also discloses the clinical study protocols and results in accordance with the provisions of applicable laws or regulations, if any, in the respective country.

Clinical study databases

US National Library of Medicine ClinicalTrials.gov: https://www.clinicaltrials.gov/

EU Clinical Trials Register (EudraCT database): https://www.clinicaltrialsregister.eu/ctr-search/search

JAPIC Clinical Trials Information Clinical study synopsis: https://www.clinicaltrials.jp/cti-user/common/Top.jsp

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

Japan Registry of Clinical Trials: https://jrct.niph.go.jp/

However, Ono does not guarantee that the information provided in clinical study databases managed by a third party is accurate and up-to-date. Therefore, Ono does not accept any legal responsibility for any issues arising from the use of information obtained from such clinical study databases.

Sharing Clinical Study Data with Researchers

Upon request of researchers, Ono may share data from our sponsored clinical studies in patients, which are included in the NDA documents for our products that have been approved for marketing or additional indications by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) since January 1, 2014. However, Ono does not share clinical study data that does not meet our criteria for sharing clinical study data such as the following: clinical study data that are prohibited from being shared with a third party on the basis of legal issues, agreements with co-development companies, or the consent received from patients; clinical study data with risk of compromise to Ono’s commercial position (e.g., interfering with confidential information or intellectual property rights). The clinical study data to be shared is processed so that an individual person cannot be identified directly.

Before the clinical study data is shared, researchers will be reviewed by the review committee composed of third-party specialists. Ono provides researchers who pass this review with the network environment that enables them to share the clinical study data after conclusion of an agreement on clinical study data sharing.
Researchers who wish to use clinical study data may access the following website: Clinical Study Data Request.com

https://www.clinicalstudydatarequest.com/

Handling of Personal Information

Regarding personal information that is related to the disclosure of clinical study information, Ono obtains personal information in compliance with all applicable laws and regulations. Ono collects personal information for a legitimate purpose in accordance with all applicable laws and regulations and limits its use of that personal information to the applicable purpose. Furthermore, Ono takes and maintains risk management, security and organisational measures that are compliant with all applicable laws and regulations. Ono recognises and respects rights of all data subjects in accordance with applicable laws and regulations. For further details on our handling of personal information, please follow the Privacy Policy link below.