Amgen's Mission
Amgen's mission is to serve patients.  As a science-based, patient-focused organization, we will follow the path of science, wherever it may lead, to discover and develop innovative therapies to treat grievous illnesses. 

Amgen's Philosophy
Innovative therapies can be developed only in partnership with patients who participate in clinical trials and with physicians who provide the primary care for such patients.  In appreciation of, and respect for, patients' altruism and physicians' central role in patient care, Amgen commits to communicating openly and sharing clinical trial information, both positive and negative, throughout the clinical development process.  We will do this by listing clinical trials on one or more publicly accessible Web sites, including the National Library of Medicine's clinical trial databank (clinicaltrials.gov), and by making clinical trial results available on one or more publicly accessible Web sites, including PhRMA's Web site (clinicalstudyresults.org). 

Amgen has developed this policy to ensure that our practices for listing clinical trials and publicly disclosing trial results are transparent, responsible, and consistent with Amgen's values.  This policy applies to all Amgen-sponsored clinical trials of Amgen products, worldwide.  For clinical trials involving products partnered with third parties, Amgen will seek to allow the listing of the trials and reporting of trial results consistent with this policy.

Listing of Clinical Trials
Amgen is dedicated to ensuring access to information for patients through listing clinical trials on one or more publicly accessible Web sites.  We are committed to full compliance with the laws requiring the listing of clinical trials for severe and life-threatening illness on clinicaltrials.gov.  In addition, we commit to list on this site all phase 2, 3, and 4 clinical trials that are sponsored by Amgen and that enroll patients in studies designed to test safety or efficacy, or both.  Information on many Amgen-sponsored clinical trials is also available on amgentrials.com and centerwatch.com, both of which are publicly available resources of clinical trial information for patients.

Reporting of Clinical Trial Results
Amgen is committed to the timely communication of scientifically valid results, positive and negative, from clinical trials that enroll patients and test the safety or efficacy or both of our products.  Avenues for such public communications will include the following:

In communicating clinical trial results, Amgen will maintain the highest ethical standards to ensure quality information.  This includes endorsement of industry guidelines known as the Good Publication Practice (GPP) guidelines¹ for pharmaceutical companies (gpp-guidelines.org).  It is our policy to follow not only the GPP guidelines, but also the guidelines sponsored or supported by national and international medical journal editors^2-4 and those of individual journals and the guidelines of the Pharmaceutical Manufacturers Association (PhRMA).⁵

What clinical trials will Amgen make public?
For marketed products, Amgen commits to publicly communicate scientifically valid results for both the primary and secondary endpoints for, at a minimum, all worldwide phase 2, 3, and 4 studies evaluating the safety or efficacy or both of all Amgen products in patients.

Only a fraction of products tested in clinical trials are submitted for regulatory approval.  For investigational products that have been determined, after clinical testing, to no longer warrant further development, Amgen commits to publicly communicate, regardless of study outcome, medically or scientifically important information from, at a minimum, all Amgen-sponsored phase 2 and 3 studies of safety or efficacy or both that enroll patients. 

In accordance with the GPP guidelines, Amgen does not support duplicate or redundant publications, but it does support secondary publications that explore scientifically sound alternative analyses or groupings of data.  These submissions should not precede publication of the full study and should include reference to the original publication and the unique protocol number of the study.

How will Amgen disclose trial results?
Amgen will disclose all clinical trial results on one or more publicly available on-line registries, including PhRMA's Web site (clinicalstudyresults.org).  Amgen will seek to publish results in peer-reviewed medical journals, subject to the discretion of the journal editors.  For study results that are disclosed in a peer-reviewed journal, a citation and the PMID (PubMed Identification) number will be posted on the Web site.  A scientific, nonpromotional summary of the data also will be posted for all studies registered.

When will Amgen make clinical trial results available to the public?
Amgen commits to post clinical trial results in accordance with these timeframes:

For investigational products that obtain regulatory approval, including new approved uses for marketed products, Amgen will submit the results of clinical trials for peer-reviewed publication and/or other publicly available scientific communication, within one year of product launch.  After publication, for study results that are disclosed in a peer-reviewed journal, a citation and the PMID number will be posted on the Web site.  A scientific, nonpromotional summary of the data also will be posted. 

For investigational drug candidates that will no longer be developed, including new uses that will not be pursued for marketed products, Amgen will collaborate with external investigators to submit manuscripts for publication within 24 months after the decision to discontinue product development.  Amgen also will post a summary of the data.  If the information is determined to be medically important, efforts will be made to disclose the information more rapidly.  Citations and PMID number, as well as scientific, nonpromotional summaries of the findings will be posted on publicly available Web sites.

For studies conducted after FDA approval, Amgen will submit the results to a peer-reviewed journal, within one year of study completion, as defined by last patient coming off study.  Upon publication, Amgen will post the appropriate citation and PMID number.  Amgen also will post a scientific, nonpromotional summary of the data on publicly available Web sites.

Period of coverage
All studies initiated after 1 July 2002 will be covered by this policy.

References

1. Wager E, Field E, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149-154.
2. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Ann Intern Med. 1997;126:36-47. icmje.org (accessed 12 Aug 2004)
3. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-639.
4. Moher D, Shulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality or reports of parallel-group randomised trials. Lancet. 2001;357:1191-1194.  consort-statement.org  (accessed 23 May 2005)
5. Pharmaceutical Research and Manufacturers of America (PhRMA).  Updated principles for conduct of clinical trials and communication of clinical trial results.  phrma.org (accessed 29 July 2005)