Sponsor Specific Details:
Sumitomo Dainippon Pharma/Sunovion Pharmaceuticals, Inc.

Sumitomo Dainippon Pharma/Sunovion Pharmaceuticals, Inc. (hereinafter referred to as DSP/Sunovion) will list Phase 2 to 4 DSP/Sunovion-sponsored interventional clinical studies conducted in patients that form part of the submission package for medicines and indications approved in the United States (US), the European Union (EU) or Japan, after 01 January, 2014.

DSP/Sunovion will not share clinical data in the following circumstances:

• Where data labels and/or supporting documents are not available in English.
• When there is a reasonable likelihood that individual patients could be re-identified, for example, in clinical studies in rare diseases, single-center studies, or other studies with a small number of participants.
• Where clinical data that DSP/Sunovion has collected is subject to legal, contractual or consent provisions that prevent further sharing of that data.
• Where agreement with a co-development, co-research, or co-marketing/co-promotion partner for a compound or product does not allow DSP/Sunovion to disclose clinical data.
• Where use of the clinical data disclosure could lead to commercial competitive risk, such as ongoing regulatory, governmental, and/or legal proceedings.
• When it may be necessary to protect DSP/Sunovion’s commercial interests (confidential information, intellectual property rights, etc.)
• When prematurely discontinued studies have yielded insufficient enrolment/exposure to warrant analysis. Interim data from completed or ongoing clinical trials will not be shared.
• When substantial practical constraints exist that may prevent DSP/Sunovion from providing access to data (e.g., issues related to the size of databases from genetic studies).
• In exceptional circumstances, access to data may be declined by the sponsor, for example where there is a potential conflict of interest or an actual or potential competitive.

Once a product has been approved for the given formulation(s) in the given indication(s) and the initial results from the study have been accepted for publication, the related studies will be listed. The list of studies will be will be reviewed at least annually and updated as

Patients agree to take part in DSP/Sunovion clinical studies by signing an informed consent. The consent provides permission to study the medicine or disease identified in the document. Further research requests by researchers must be consistent with the study medicine/disease identified in the original patient informed consent.

Beginning in FY2018 for all DSP/Sunovion studies, patients will be asked to give permission for broader analyses by DSP/Sunovion or researchers. This expanded permission will allow researchers to answer additional scientific questions related to the study medicine/disease evaluated in the original DSP/Sunovion study.

• In exceptional circumstances, access to data may be declined by DSP/Sunovion, for example, where there is a potential or actual conflict of interest.
• DSP/Sunovion will not provide data to external researcher unless the researcher pledges to seek publication of his/her research results in a peer-reviewed journal. Researchers must agree to provide a copy of the summary results and draft manuscript to DSP/Sunovion for review prior to journal submission. DSP/Sunovion will not seek to influence the content of a publication or the opinions of the researcher. Other than the redaction of DSP/Sunovion’s confidential information, the final decision whether to accept any comments made by DSP/Sunovion remains with the researcher.

Where available and consistent with the proposal, the following anonymized patient-level data and information will be provided for each clinical study:

Raw Dataset. This is the dataset containing the collected information for each patient in the clinical study

Analysis-ready dataset. This is the dataset that DSP/Sunovion used for its analyses

Protocols (with any amendments or addenda): These documents describe the objectives, design, methodology, statistical considerations, and organization 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 tabulation dataset.

Statistical analysis plan. This describes procedures for data handling and methods of analysis that DSP/Sunovion used for the analysis of 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 such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA). Appendices which include patient level data are not included as these data are provided in the anonymized datasets. Appendices that contain no patient relevant data (e.g., audit certificates or manuals from providers of various diagnostic services) as well as individual patient-level data (e.g., narratives) will not be provided. The data from narratives will of course be contained - in aggregated fashion - in the datasets provided by to DSP/Sunovion.

Documents will be redacted to protect the personal data of study participants, study personnel, and DSP/Sunovion employees, and to protect DSP/Sunovion’s commercially confidential information and intellectual property rights.

Requests for access to additional clinical study data will be considered on a case-by-case basis.

Researchers may inquire about the availability of data from DSP/Sunovion clinical studies that are not listed on the site. These requests will be considered on a case-by-case basis.

Access to study documents without patient-level data:
Researchers may request access to clinical study documents, without patient-level data (e.g., the Clinical Study Report), by completing the online enquiry form.

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

• Whether the studies have been published or accepted for publication, and whether the researchers’ enquiry is for approved medicines will be taken into consideration. It is DSP/Sunovion’s practice to provide access to patient-level data only after; (1) the regulatory approval of the medicine or indication and (2) the initial results from studies have been accepted for publication.
• Whether DSP/Sunovion has the legal authority to provide the data. For example, DSP/Sunovion may not have the legal authority to provide certain data because the medicine has been out-licensed to another company.
• DSP/Sunovion will take appropriate measures to protect personally identifiable information, and therefore will only share data with researchers that have been appropriately anonymized. Furthermore, DSP/Sunovion will decide whether it is feasible to anonymize the requested data without compromising the privacy or confidentiality of study participants. For example, satisfactory anonymization of data from studies of rare diseases with small patient numbers is more difficult to achieve and, therefore, would be reviewed on a case-by-case basis.
• Whether Sumitomo Dainippon/Sunovion considers that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from certain studies or considerable operational constraints, particularly for older studies, such that DSP/Sunovion reserves the right to reject requests because the retrieval and provision of the requested data would be impractical.
• Whether DSP/Sunovion is able to provide the requested data. For example, some non-interventional (or observational) studies use data from third party databases under license agreements which may prohibit DSP/Sunovion from providing third parties access to the data. In these cases the researcher may be required to seek access to the data directly from these third party database owners.
• Whether the trial data are available in electronic format.

Sunovion registers its local and global interventional clinical studies on: https://clinicaltrials.gov
DSP: http://www.japic.or.jp/