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Sumitomo Pharma/Sunovion Pharmaceuticals, Inc.

About We strive to serve and create value for patients every day. By developing innovative therapies that treat serious Central Nervous System (CNS) conditions, science leads the way—guiding us to a healthier tomorrow.
How we share on the Vivli Platform
 Studies available for sharing will be listed and searchable on the Vivli platform. Data requestors should use the Vivli Data Request Form to request Sumitomo Pharma/Sunovion Pharmaceuticals, Inc. (hereinafter referred to as SMP/Sunovion) data packages(s).
If the request is approved, researchers will need to sign a Data Use Agreement. The anonymized data and redacted documents will be provided in a secure research environment on Vivli to further protect participant privacy.
Studies Listed for Sharing Sumitomo Pharma/Sunovion Pharmaceuticals, Inc. (hereinafter referred to as SMP/Sunovion) will list Phase 2 to 4 SMP/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.
Exceptions SMP/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 SMP/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 SMP/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 SMP/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 SMP/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.
When Studies are available for sharing 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 reviewed at least annually and updated as appropriate.
Additional Conditions for Access Patients agree to take part in SMP/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 SMP/Sunovion studies, patients will be asked to give permission for broader analyses by SMP/Sunovion or researchers. This expanded permission will allow researchers to answer additional scientific questions related to the study medicine/disease evaluated in the original SMP/Sunovion study.
In exceptional circumstances, access to data may be declined by SMP/Sunovion, for example, where there is a potential or actual conflict of interest.
SMP/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 SMP/Sunovion for review prior to journal submission. SMP/Sunovion will not seek to influence the content of a publication or the opinions of the researcher. Other than the redaction of SMP/Sunovion’s confidential information, the final decision whether to accept any comments made by SMP/Sunovion remains with the researcher.
What information will be provided 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 SMP/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 SMP/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 SMP/Sunovion.

Documents will be redacted to protect the personal data of study participants, study personnel, and SMP/Sunovion employees, and to protect SMP/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.
Questions or enquiries Researchers may inquire about the availability of data from SMP/Sunovion clinical studies that are not listed on the site. These requests will be considered on a case-by-case basis.
Review Criteria for Data Requests
  • The analysis can be conducted in the data access system.
  • The scientific rationale and relevance of the proposed research to medical science or patient care.
  • The qualifications and experience of the research team to conduct the proposed research.
  • If a research proposal competes with the SMP/Sunovion publication plan, SMP/Sunovion will decline the research proposal and inform the researcher accordingly. The research proposal can be re-submitted at time of publication, if the researcher desires.
  • The data requested in the research proposal are available
Data Request Review Process Access to patient-level clinical study data requires that the requestor submits a research proposal with a sound scientific rationale which is reviewed by Vivli and Sunovion/SMP for completeness and for compliance with the access and review criteria listed above. Furthermore, an independent external review panel reviews the proposal and considers, among other things, the scientific rationale and relevance of the research and the qualifications of the research team (see Independent Review Panel for more information)
Access to study documents without participant-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.
Anonymization Standards   Anonymization Standards
Clinical Study Register or Website Sunovion registers its local and global interventional clinical studies on: https://clinicaltrials.gov

SMP: https://jrct.niph.go.jp/, http://www.japic.or.jp/ and https://clinicaltrials.gov
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