Sponsor Specific Details: ONO Pharmaceutical Co.,Ltd

ONO-sponsored clinical studies in patients, which are included in the application documents for its products that have been approved for marketing or additional indications by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) or by the FDA or the EMA individually (if the approval application is submitted to either one of them) since January 1, 2014. In addition, Phase IV studies, for which implementation is specified as a condition for approval, are applicable.

ONO does not share clinical study data in the following circumstances.

・Processing to prevent the direct identification of an individual person would be difficult (e.g., single-center clinical studies, small-scale clinical studies with few enrolled patients, and clinical studies in patients that have very rare diseases with small sample sizes).
・The clinical study data is not available in English.
・Sharing the clinical study data would be technically difficult (e.g., the file format used for the clinical study data is out of date and not compatible with current systems or software).
・The sharing of data with a third party is prohibited legally or based on agreements with the co-development companies or from the viewpoint of the consent received from the patients.
・There would be a conflict of interest (COI) between the researchers and ONO.
・The risk of compromise to ONO’s commercial position (e.g., disclosure of confidential information or impact on intellectual property) exists (the data can be shared once this risk no longer exists).
・The clinical study was discontinued before completion (e.g., insufficient accumulation of patients or inadequate efficacy).

Furthermore, in principle, ONO does not share data from interim analyses or data from ongoing clinical studies.

When the stated criteria are satisfied.

Not applicable

Where available, the following anonymised patient level data and information is provided for each clinical study.

Raw dataset or SDTM datasets. These are the data collected for each patient in the clinical study. SDTM is the raw data mapped to CDISC standards.

Analysis-ready dataset. This is the dataset used for ONO's analysis.

Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.

Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) ONO used for the study.

Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities. Appendices which include patient level data are not included as these data are provided in the datasets ONO provide.

Researchers can enquire about the availability of data from ONO clinical studies that are not listed on the site before they submit a research proposal.

Researchers can enquire about access to clinical study documents such as Clinical Study Report by completing the online enquiry form.

Whether the studies have been published or accepted for publication and whether they researched authorized medicines or terminated compounds. It is ONO policy to provide access to patient level data only after authorization or termination of the medicine and acceptance of the study for publication in the scientific literature.

Whether ONO has the legal authority to provide the data. For example, ONO may not have the legal authority because the medicine has been out-licensed to another company.

Whether ONO considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.

Whether ONO considers that there are any practical constraints to providing access to the data.

The resources (costs) for ONO to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and ONO may turn down requests on this basis.

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