Overview of researcher access to patient-level data
Researchers can submit research proposals and request anonymized patient-level data from Otsuka-sponsored clinical studies. Otsuka is committed to consider sharing patient-level data filed with the US and EU medicines regulatory agencies on or after January 1, 2014. Clinical studies will be listed on the website after regulatory approval(s). More details are contained in the Study List section.
In addition to the studies listed on this website, researchers are encouraged to contact Otsuka about the availability of clinical data for approved products in the US, EU, and Japan and for programs that have been announced by Otsuka as terminated. Submission of a research proposal including, for example, a rationale for the research, a research question, a statistical analysis plan, a publication plan and a declaration of any potential conflicts of interest, are key steps in the process to obtain access to the requested data.
Research proposals requesting patient-level data are reviewed by an Independent Review Panel (IRP) at WIRB Copernicus Group. Research proposals for non-listed studies are examined on a case-by-case basis by Otsuka in consultation with the IRP.
Researcher must be aware that some individual data may need categorization or suppression due to data anonymization processes. Also, researchers must be able to use the R shared software for statistical analysis or Python3, and support for the software will not be provided by Otsuka.
Otsuka will not share patient-level data when or until:
- 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 (ex., 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
Inquiries and Data Request Submissions
For inquiries on availability of data of interest, researchers should contact Otsuka. Please note that patient-level data from clinical studies completed more than 10 years before the date of data request may be difficult to share due to data formatting or other technical reasons.
For the listed studies on this website, a researcher must first create an account in a separate website of WIRB Copernicus Group company, specify a clinical study (or studies) of interest and submit a research proposal for evaluation by the Independent Review Panel. In cases where informed consent or technical constraints do not allow Otsuka to share patient-level data, the request will be addressed by providing redacted clinical study reports.
If Otsuka has determined that contents on the inquiry form or request form include safety information such as adverse drug reactions, our pharmacovigilance staff will contact you. Please cooperate on any such inquires that you receive.