Eisai Clinical Trials

Our Commitment

Statement

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, PhRMA, EFPIA, BIO and IFPMA with respect to increased clinical trial transparency. Eisai also 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 the principles set forth by BIO(USA): Principles on Clinical Trial Data Sharing. Eisai commits to sharing clinical trial data in compliance with all appropriate regulatory guidelines and local laws, whilst safeguarding the privacy of patients.

Enhancing Data Sharing with Researchers

Eisai submits for publication in scientific literature, by poster, or oral presentation at scientific meetings the results of its Phase 3 studies and of studies where results are considered to be of significant medical importance.

Eisai commits to sharing data upon request from qualified scientific and medical researchers from clinical trials in dossiers for medicines and indications submitted and approved from 1st January 2014 in the United States (US) and the European Union (EU).

Eisai has a process to evaluate enquiries and requests from qualified researchers who wish to access clinical trial data and associated information, such as Clinical Study Reports (CSRs), Statistical Analysis Plan (SAP) and Protocol. Please visit ClinicalStudyDataRequest.com (CSDR).

Any patient level data disclosed by Eisai is anonymized and consistent with the patients’ informed consent. Eisai does not grant access to such patient level data if the applicable patient’s consent restricts and/or prohibits further transfer to third parties.

Enhancing Public Access to Clinical Study Information

Eisai discloses information on its sponsored trials via registration on at least one publicly accessible registry. Eisai shares summaries of clinical trial results on these repositories in accordance with the applicable timelines.

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 from 1st January 2014. Eisai makes this information available whilst protecting patient privacy, publication rights and commercially confidential information (CCI) and within a reasonable time following approval of the product.

To access information on clinical trials run by Eisai please use the following links:

Clinicaltrials.gov

EU Clinical Trials Register

Sharing Results with Patients Who Participate in Clinical Trials

Eisai will make available factual plain language summaries of the CSRs in compliance with applicable regulatory guidelines, and local laws. Eisai is committed to improving health through continuing research in areas of unmet need and sharing results of the trials.