Study sponsor: Eisai
||Eisai sponsored Phase 2 and 3 studies and phase 4 interventional studies will be
listed as described below:
- For products and indications submitted and approved by EMA and FDA, after 1st
January 2014 and only after the primary manuscript describing the results has been
accepted for publication. An Enquiry Form can be submitted for an unlisted study
to confirm availability.
||Eisai will not share clinical data:
- where there is reasonable likelihood that a patient could be re-identified
- where clinical data does not exist in a format that can be readily anonymised
- where supporting documents are not in English
- where agreement to disclosure clinical data is not gained with a co-development/research/marketing/promotion
partner for a compound/product
- where data has been collected subject to legal, contractual or consent provisions
that prevents further sharing of clinical data.
|When studies are listed
||When the stated criteria are satisfied.
|Additional conditions for data access
||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
|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 Eisai’s analysis.
Protocols with any amendments. This describes the objectives, design,
methodology, statistical considerations, and organisation 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 dataset.
Reporting and analysis plan. This describes methods of analysis,
procedures for data handling and data displays (figures and tables) Eisai used for
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 Eisai employees, and to protect Eisai’s commercially confidential
information and intellectual property rights. Requests for access to full CSRs will
only be considered if the full CSR is available in English language. Appendices
which include patient level data are not included. Eisai will not share case narratives.
||Researchers can enquire about the availability of data from Eisai clinical studies
that are not listed on the site before they submit a research proposal.
|Review criteria for enquiries
||The primary manuscript of the study has been published or accepted for publication.
The studies are for the formulation and indication approved by the FDA and EMA
Eisai will not share clinical data:
If there is reasonable likelihood that a patient could be re-identified
If clinical data disclosure leads to commercial competitive risk.
If agreement to disclosure clinical data is not gained with a co-development/research/marketing/promotion
partner for a compound/product.
If data has been collected subject to legal, contractual or consent that prevents
further sharing of clinical data.
If there are considerable operational constraints (costs, resource) to providing
access to the data.
|Clinical study register