Amgen Guidelines for Publications

Amgen is committed to the highest scientific and ethical standards for publications and is dedicated to providing scientifically accurate, fair, and well-balanced publications to the scientific community (eg, manuscripts, review articles, abstracts, posters, and/or oral presentations that contain data from Amgen-sponsored studies, have Amgen authors, or for which Amgen provides writing and/or editorial assistance). We submit at least the primary analysis of all completed Amgen-sponsored phase 2 and phase 3 studies to congresses or peer reviewed journals within 18 months of trial completion. Beyond results of individual clinical trials, we also routinely publish data from observational studies and safety registries that reflect real-world use of Amgen's products, results from integrated- and meta-analyses that permit comparative research, and biomarker studies.

Authorship Criteria

Amgen’s principles for authorship of publications are consistent with criteria developed by the International Committee of Medical Journal Editors (www.icmje.org)¹:

• Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
• Drafting the work or revising it critically for important intellectual content; AND
• Final approval of the version to be submitted/presented; AND
• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Amgen prohibits the practices of guest authorship, ghost writing, or plagiarism on publications. Guest authoring is the practice in which the names of individuals who contributed little to no content on the publication appear on the byline. Ghost writing is the practice in which individuals who wrote the publication are neither acknowledged nor listed on the byline.

Drafting the Publication

Authors participate and provide substantive input throughout the development of a publication.

Access to Study Results

Amgen provides the pertinent study results supporting a publication to all authors. At an external author’s request, access to additional data from the study may also be provided.

Acknowledgments and Disclosures

It is Amgen’s policy to acknowledge financial support, technical assistance, or contributions of those who do not meet the criteria for authorship (eg, a medical writer or other subject-matter expert).

All authors are responsible for recognizing, acknowledging, and disclosing financial or potential conflicts of interest that might bias their work, as required by the pertinent journal or congress.

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