Clinical Trial Data Sharing Request
Thank you for your interest.
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.
Amgen will consider data sharing requests relating to clinical trials and observational studies for products and indications that have been approved in both the U.S. and Europe (or approved in one of the regions and Amgen has determined it will not submit the product/indication for regulatory review in the other region). Further clinical trials conducted on approved products and indications will be available 18 months after the study has finished and/or in accordance with protection of publication rights. Amgen will also consider data sharing requests relating to clinical trials for products/indications for which Amgen has terminated the clinical development activities and these data will not be submitted to regulatory authorities.
Your data sharing request will be reviewed by a committee of internal advisors. In general, Amgen does not support external research questions that involve access to individual patient level data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. 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 of the final decision and will 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.