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CLINICAL TRIAL DATA DISCLOSURE

Eisai Policy on Clinical Trial Data Access and the Disclosure of Clinical Trial Information

Eisai is committed to enhancing patient health through transparency in its clinical research and the responsible sharing of clinical trial data in a manner in keeping with our hhc mission. Eisai supports the positions of JPMA, BIO and IFPMA with respect to increased clinical trial transparency and commits to sharing of clinical trial data in a manner that is consistent with the principles laid out by EFPIA (EU) and PhRMA (USA): Principles for Responsible Clinical Trial Data Sharing, and in compliance with all appropriate regulatory guidelines and local laws whilst safeguarding the privacy of patients.

Registration of Clinical Trials and Disclosure of Clinical Trial Results

Eisai discloses information on its sponsored trials via registration on at least one publicly accessible registry. This registration includes a brief outline of the trial protocol and the status of the trial. Following approval of a new medication or a new indication, Eisai shares summaries of the clinical trial results on these repositories. Eisai commits to disclosing synopses of clinical study reports for clinical trials in all dossiers submitted to and approved by FDA and EMA and/or other national competent authorities of EU Members States since 1st January.
Eisai is also working to develop summaries of clinical trial results which can be made available to patients who have participated in Eisai sponsored clinical trials.

To access clinical trial information and result summaries please use the following links.

Publishing results of Clinical Trials

Eisai also commits to publishing the results of Phase 3 clinical trials in scientific literature, or by poster or oral presentation at scientific meetings, and those clinical trial results of significant medical importance irrespective of whether the results are positive or negative.

Access to Clinical Trial Data

Eisai has joined a multi company portal site through which researchers who wish to request access to clinical trial data and associated information in order to conduct further research can submit their request. Requests for data will be reviewed and approved by an Independent Review Panel (IRP) based upon a number of criteria including the legitimacy of the research question and the qualifications of the researcher. Following approval by the IRP, access to the anonymized requested data will be provided by Eisai.
Data will be shared for trials included in dossiers submitted to and approved by FDA and EMA after 1st January 2014 and only after the primary manuscript describing the results has been accepted for publication, and only if clinical data disclosure will not lead to commercial competitive risk. In all cases data will not be shared if the privacy of patients cannot be safe guarded.

To submit a request, researchers should use the following link:

Access to Full Clinical Study Reports

Eisai can provide access to full clinical study reports from Eisai sponsored trials on request. Please contact Eisai directly by clicking on the icon below to request access to clinical study reports and any other associated information.

For any other requests or questions regarding information on clinical trial and data disclosure please contact Eisai directly by clicking on the link below:

For Inquiries about clinical trial data disclosure
Clinical Trial Summary Result

We will endeavor to respond to your inquiry as quickly as possible, however please be aware that there may be some delay depending on the nature of the inquiry and other factors.