Study sponsor: Daiichi
||Daiichi Sankyo will list Phase 2, Phase 3 and Phase 4 Daiichi Sankyo-sponsored interventional
clinical studies in patients that form part of the submission package for medicines
and indications approved in the United States (US) and the European Union (EU),
after 1 January 2014
||Studies where there is reasonable likelihood that patients’ anonymity cannot be
maintained. For example in very rare diseases, studies with very low patient numbers
or studies performed at a single centre.
When necessary to restrict information to protect commercially confidential information
and intellectual property rights on rare occasions.
Data collected subject to legal, contractual or consent provisions that prevent
further sharing of clinical data will be excluded.
|When studies are listed
||Studies are listed after the medicine and indication have received EU and US marketing
approval, on or after the 1 January 2014 and after the results from the studies
have been accepted for publication.
|Additional conditions for data access
||Access may be declined on rare occasions, for example, where there is a potential
conflict of interest or an actual or potential competitive risk.
The external research request must not extend beyond the limitation of participants’
For future DS studies patients will be asked to give permission for broader research
beyond the original
|Datasets and documents provided
||Where available, the following anonymised patient level data and information is
provided for each clinical study.
Raw dataset. This is the data collected for each patient in the
Analysis-ready dataset. This is the dataset used for Daiichi Sankyo’s
Protocols with any amendments. This describes the objectives, design,
methodology, statistical considerations, and organisation of a clinical trial and
information about all amendments.
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) Daiichi Sankyo
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
such as the Food and Drug Administration (FDA) and the European Medicines Agency
(EMA). Documents will be redacted to protect personal data of study participants,
study personnel, and Daiichi Sankyo employees, and to protect Daiichi Sankyo’s commercially
confidential information and intellectual property rights. Appendices which include
patient level data are not included. Daiichi Sankyo will not share case narratives.
||Researchers can enquire about the availability of data from Daiichi Sankyo clinical
studies that are not listed on the site before they submit a research proposal.
In addition, researchers can enquire about access to clinical study documents only
(without patient level data, such as the Clinical Study Report) by completing the
online enquiry form.
|Access to study documents without patient-level data
||Daiichi Sankyo also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies) via the Enquiry Facility.
|Review criteria for enquiries
||The primary manuscript of the study has been published or accepted for publication.
Whether Daiichi Sankyo 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 prevent Daiichi Sankyo from providing access to the
data. Researchers may seek access to data directly from these third party databases
under similar agreements.
Whether Daiichi Sankyo has the legal authority to provide the data. For example,
Daiichi Sankyo may not have the legal authority because the medicine has been out-licensed
to another company.
Whether Daiichi Sankyo 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.
If there are considerable operational constraints (costs, resource) to providing
access to the data.
|Clinical study register