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|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 America, Inc. (hereinafter referred to as SMP) 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 America, Inc. (hereinafter referred to as SMP) will list Phase 2 to 4 SMP-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.
|SMP will not share clinical data in the following circumstances:
|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 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 studies, patients will be asked to give permission for broader analyses by SMP or researchers. This expanded permission will allow researchers to answer additional scientific questions related to the study medicine/disease evaluated in the original SMP study.
In exceptional circumstances, access to data may be declined by SMP, for example, where there is a potential or actual conflict of interest.
SMP 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 for review prior to journal submission. SMP will not seek to influence the content of a publication or the opinions of the researcher. Other than the redaction of SMP’s confidential information, the final decision whether to accept any comments made by SMP 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 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 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.
Documents will be redacted to protect the personal data of study participants, study personnel, and SMP employees, and to protect SMP’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 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
|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 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.
|Clinical Study Register or Website
|https://jrct.niph.go.jp/, http://www.japic.or.jp/ and https://clinicaltrials.gov