Sponsor Specific Details: 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 the stated criteria are satisfied.

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 risk.

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 clinical study.

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 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 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.

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.

http://ClinicalTrials.gov