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.
SMP/Sunovion will not share clinical data in the following circumstances:
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 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.
Where available and consistent with the proposal, the following anonymized patient-level data and information will be provided for each clinical study:
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.
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.