Clinical Trial Data Sharing Request
Thank you for your interest.
Amgen collaborates with external medical and scientific researchers on a case-by-case basis. Qualified medical/scientific researchers may submit for consideration a data sharing request. The data sharing request must contain the research objectives, the Amgen product(s) and Amgen study/studies in scope, the endpoints/outcomes of interest, the statistical analysis plan, data requirements, and publication plan.
Your data sharing request will be reviewed by a committee of internal advisors. If the internal review committee declines your request, a Data Sharing Independent Review Panel (DSIRP) will arbitrate and make the final decision. Amgen will notify you to confirm if your request has been: Approved; Approved with conditions; Rejected with comments (a revised data sharing request can be re-submitted); or Rejected.
Following the approval of a data sharing request, Amgen will de-identify patient-level data and anonymize documents in accordance with local legal and ethical regulations.
Access to data is governed by the terms of a data sharing agreement, which the researcher must sign before Amgen will grant access to the data in scope of the approved request. The de-identified patient level data is provided to the researcher in a secure manner, and the researcher is responsible for protecting the confidentiality and integrity of the data while the research is conducted.
Researchers are required to send Amgen a copy of any manuscripts or items for publication generated from the research for review prior to their publication. Amgen can provide comments but cannot exercise editorial control over the publication and does not have the authority to stop the publication. Once the publication process has been completed, the researcher must return the data or confirm secure disposal of the data, and the data sharing agreement ends.
If you are a medical/scientific researcher interested in collaborating with Amgen and wish to request access to clinical trial data, please complete the data sharing request form and submit the completed form and any additional attachments to email@example.com.
Amgen will reply by email with confirmation your request has been received. Amgen will also confirm all the required information has been provided.