Data Sharing

Supporting Advancement of Public Health

Otsuka is committed to providing qualified external researchers with access to anonymized patient-level data and Clinical Study Reports (CSRs) from eligible trials.

Overview

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.

Researchers must submit a proposal including:

Research rationale and question

Statistical analysis plan

Publication plan

Declaration of potential conflicts of interest

Submit Your Proposal

Research proposals requesting patient-level data are reviewed by an Independent Review Panel (IRP). Research proposals for non-listed studies are examined on a case-by-case basis by Otsuka in consultation with the IRP.

If you are a qualified researcher interested in collaborating with Otsuka and would like to access clinical trial data, click the link below.