Clinical Trial Data Sharing Request

Information available

Examples of data that may be requested include, but are not limited to, de-identified individual patient-level datasets (including data dictionaries, dataset specifications), study protocols, statistical analysis plans, clinical study reports, and/or informed consent forms. Data/metadata will be provided as necessary to address the research question in an approved request.

Studies in scope

Requests may be submitted for data owned by Amgen from any of its completed clinical trials and observational studies relating to approved uses (eg, indication, dosage form) of products approved in both the US and Europe (or approved in one of the regions if Amgen has determined the data will not be submitted for regulatory review in the other region).  Data sharing requests will also be considered if clinical development of the product/indication/use discontinues and the data will not be submitted to regulatory authorities.

Time frame

Data sharing requests for studies with products/uses approved in both the US and Europe may be submitted 18 months after the study has ended. Requests for studies involving unapproved products/ uses may be submitted immediately after approval in both the US and Europe (whichever is later); or after clinical development discontinues and it has been determined that the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request.

Submitting a request

Qualified medical/scientific researchers may submit for consideration a data sharing request containing the research objectives, Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, and publication plan. To submit your request, please complete the data sharing request form and send the completed form and any additional attachments to datasharing@amgen.com.

Amgen will reply by email with confirmation your request has been received. Amgen will also confirm whether all the required request information has been received.

Review

Your research proposals will be reviewed by a committee of internal advisors. For clinical trials that are subject to agreements with co-development partners, Amgen will liaise with the applicable partners regarding any data sharing requests. 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 outcome of the internal review is to decline the request, a Data Sharing Independent Review Panel (DSIRP) will arbitrate and make the final decision. The following individuals form the DSIRP:

Amgen will notify you of the final decision and will confirm if your request has been:  Approved; Rejected with comments; or Rejected. A request that has been “Rejected with comments” may be reconsidered if it is revised and re-submitted.

Requests that pose an actual or potential conflict of interest or competitive risk, however, may be declined at Amgen’s sole discretion and without further arbitration.

Data access

Access to data is governed by the terms of a data sharing agreement. The researcher must agree to these terms and sign the agreement before Amgen will grant access to the data in scope of the approved request.

Following the approval of a data sharing request and the signing of the agreement, Amgen will de-identify patient-level data and anonymize documents in accordance with local legal and ethical regulations. The de-identified patient level data will be provided directly 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.

Completing a project

Under the terms of the data sharing agreement, researchers can submit their findings to journals or conferences after the primary results of the study have appeared in manuscript form. Researchers must send Amgen a copy of any manuscripts or items for publication generated from the research for Amgen’s review prior to their publication. Amgen can provide comments but cannot exercise editorial control over the publication. Researchers are expected to follow the International Committee of Medical Journal Editors’ recommendations for authors. Once the publication process has been completed, the researcher must return the data or confirm secure disposal of the data.