Sharing of Clinical Study Data
Ono believes that sharing clinical study data and results with researchers, healthcare professionals, and patients 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 industry guidelines including Good Publication Practice, applicable laws, and regulation.
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 new drug application (NDA) documents for our products that have been approved for marketing or additional indications by the US Food and Drug Administration or the European Medicines Agency 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.
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 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
- EU Clinical Trials Register (EudraCT database)
- EU Clinical Trials Information System (CTIS)
- Japan Registry of Clinical Trials
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.
Publication of Clinical Study Results
Ono complies with the IFPMA Principles for Responsible Clinical Trial Data Sharing and related guidelines such as Good Publication Practice, and proactively strives to present and publish the results from all our sponsored phase 3 clinical trials and any clinical trials of significant medical importance (including those for discontinued investigational drugs) at academic conferences and in peer-reviewed scientific journals in a timely manner regardless of whether the results are positive or negative. However, to protect intellectual property rights such as patents, the publication may be delayed for a reasonable period of time.
Handling of Personal Information