Purpose
The purpose of this policy is to ensure that our practices for publicly disclosing clinical trials and trial results are transparent, responsible, and consistent with Amgen's values and applicable regional and international laws, regulations, and guidelines.

Scope
This policy applies worldwide to all Amgen-sponsored phase 2, 3, and 4 clinical trials in studies designed to test safety or efficacy, or both of an Amgen product.

Registration of Clinical Trials
Amgen is dedicated to ensuring public access to clinical trial information through the registration of our trials on one or more publicly accessible Web sites at trial inception e.g. www.clinicaltrials.gov.

Reporting of Clinical Trial Results
Amgen is committed to the timely communication of scientifically valid results, positive and negative, from our clinical trials. Avenues for such public communication will include the following:

• Scientific, non-promotional summaries on a publicly accessible registry (e.g. www.clinicalstudyresults.org), and/or
• Peer-reviewed publications

Clinical trial results will be publicly disclosed as stated above, unless such communication would compromise publication in a peer-reviewed medical journal or contravene national laws or regulations.

Investigational Products: Amgen will post a non-promotional scientific summary of clinical trial results and/or a peer-reviewed publication within one year of an investigational product's regulatory approval or within one year of the regulatory approval of a marketed product's new indication.

Marketed Products: for clinical trials involving marketed products in approved indications conducted after regulatory approval, including investigation of new uses that will not be pursued for marketed products, Amgen will post a non-promotional scientific summary of clinical trial results and/or a peer-reviewed publication within one year of trial completion.

No Longer Developed: for investigational drug candidates that will no longer be developed, Amgen will post a non-promotional scientific summary of clinical trial results and/or a peer-reviewed publication within one year after the decision to discontinue product development.

If clinical trial results are determined to be medically important, results will be disclosed as soon as possible.

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. http://www.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. http://www.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. http://www.phrma.org/clinical_trials/ (accessed 29 July 2005)
6. Good Publication Practice (GPP) guidelines for pharmaceutical companies (www.gpp-guidelines.org).
7. Section 113, Food & Drug Administration (FDA) Modernization Act of 1997 (FDAMA 113), (42 USC § 282(j)
8. Title VIII, Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA), 42 USC § 282(j).