Twitter Facebook LinkedIn
Center for Global Research Data

Our Members

Celgene

For additional Information, please review the Celgene Clinical Trial Data Sharing Policy.

About Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients. 
How we share on the Vivli Platform  To obtain Celgene data, requestors must complete a data request on the Vivli platform. If the request is approved, Celgene will upload the anonymized data into the Vivli platform for use by researchers. 
Studies listed for sharing Studies supporting indications approved in both the United States and European Union on or after January 1, 2014 will be considered for sharing. 
Exceptions  Data sharing requests outside of this scope will also be considered depending on availability of the data and assessment of the scientific validity of the request.
When Studies are available for sharing  The external Scientific Review Board will consider providing qualified researchers with redacted and anonymised data from studies supporting indications approved in both the United States and European Union on or after January 1, 2014. Data Sharing requests outside of this scope will also be considered depending on availability of the data and assessment of the scientific validity of the request.
Additional Conditions for Access  None
What information will be provided  Information that will be considered for disclosure includes:  

  • patient-level clinical data (raw and derived); 
  • study-level clinical data (raw and derived); 
  • Clinical Study Reports (CSR); 
  • annotated Case Report Forms (CRF) or documents explaining data structure; 
  • Statistical Analysis Plans (SAP); and 
  • protocols. 
Questions or enquiries  Enquiry form 
Review Criteria for Data Requests The external Scientific Review Board will provide an unbiased review of research proposals submitted by researchers to ensure the proposals are robust, scientifically sound with a valid and clearly defined hypothesis, and include both an analysis and publication plan. The SRB will also evaluate the qualifications and experience of the research team to conduct the proposed research.
Data Request Review Process  Internal Celgene personnel will initially review each request to ensure alignment with the scope of the policy and completeness of the request as well as check current or expected availability of the data sets. Following the initial review, a request will be submitted to the SRB for final review and decision. 
Access to study documents without participant-level data  Access to study documents without participant level data will also be considered for sharing. Requests for this information can be initially submitted using the inquiry form. A full research proposal may be required before access is provided.
Anonymisation Standards  All data must be anonymised to protect the privacy of the patients who participated in Celgene-sponsored studies, in accordance with applicable laws and regulations and in compliance with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP). 
Clinical Study Register or Website  Celgene will continue to (1) register all Celgene-sponsored studies in individuals with disease prior to obtaining the first consent, on the public database www.ClinicalTrials.gov, regardless of where the study is being conducted, and (2) register all Celgene-sponsored studies conducted in Europe in the relevant official system. All Celgene-sponsored studies also will be registered on national registries as required by local regulations. 

View Celgene data-sharing metrics prior to March 31, 2019.