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 laws and regulations, including the provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Scope
This policy applies worldwide to all Amgen-sponsored phase 2, 3, and 4 clinical trials 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). Information to be registered will comply with the data elements requirements of FDAAA.
Reporting of Clinical Trial Results
Amgen is committed to the timely communication of scientifically valid results, both 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.clinicaltrials.gov; www.clinicalstudyresults.org), and/or
- Peer-reviewed publications
Clinical trial results will be publicly disclosed as described below.
Investigational Products:
For clinical trials conducted in support of an investigational product's regulatory approval, Amgen will post a non-promotional scientific summary and/or a peer-reviewed publication as required by applicable laws and regulations. This posting will generally occur within 30 days after the product's initial approval anywhere in the world.
Marketed Products:
For clinical trials involving marketed products conducted after regulatory approval, Amgen will post a non-promotional scientific summary and/or a peer-reviewed publication as required by applicable laws and regulations. This posting will generally occur within one year after trial completion. For clinical trials that support a new indication of a marketed product, Amgen will post a nonpromotional scientific summary and/or a peer-reviewed publication as required by applicable laws and regulations. This posting will generally occur within 30 days after a final approval decision anywhere in the world. If a clinical trial of a marketed product is discontinued early for safety reasons, medically important information will be disclosed promptly.
No Longer Developed:
For investigational drug candidates that will no longer be developed, Amgen will post a nonpromotional scientific summary and/or a peer reviewed publication within one year after the decision to discontinue product development.
In all cases, if clinical trial results are determined to be medically important, results will be disclosed promptly.
