Data Sharing

Researchers may request data from trials that completed after January 1, 2014 for products and indications approved by the FDA and/or EMA. Data sharing requests will also be considered if clinical development of the product or indication is terminated, and the data will not be submitted to regulatory authorities.

Otsuka will not share patient-level data when:

• Risks for re-identification of patients are substantial or anonymization is difficult to achieve.
• Clinical data were collected subject to legal, contractual, or consent provisions that prohibit or do not allow data sharing with third parties.
• Planned publications of study results are accepted for publication.
• Data sharing is not technically feasible (e.g., data or associated documents are not available in English, or are available only in an obsolete file format).
• Disclosure is thought to pose substantial commercial competitive risks (e.g., on drug formulation development, pharmacokinetics, etc.).
• Clinical data or documents are under regulatory review.

Completed Data Request Forms provided by Vivli are initially reviewed by Vivli for completeness. Once confirmed complete, Otsuka then reviews the completed Data Request Form.

In determining whether a specific request for access to data and clinical trial information shall be granted, Otsuka will consider the information required on the Vivli Data Request Form.

Pursuant to the U.S. Department of Justice Final Rule – Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern (28 CFR Part 202), we review on a case-by-case basis requests for studies that include US participants and where researchers are from Countries of Concern or are Covered Persons.