We register clinical trials and report clinical study results to clinical trial registries in accordance with the US Food and Drug Administration Amendments Act of 2007 (FDAAA) and EU 2001/20/EC, Article 57(2) of Regulation (EC) No 726/2004, and Article 41 of Regulation (EC) No 1901/2006 and associated guidance.
For some older trials where posting to registries is not required by law, Amgen publishes summary results on www.amgentrials.com in the form of clinical study report (CSR) synopses. More information is provided below under "Publication of Clinical Study Reports."
Amgen's compliance with clinical trial registration and disclosure requirements and commitments is within scope of our internal audit activities, and we routinely monitor compliance in this area.
In the United States:
Amgen registers clinical trials and reports clinical study results on www.clinicaltrials.gov for trials that were initiated after 27 September 2007 or ongoing as of 26 December 2007 as follows:
- Phases II-IV interventional clinical trials as well as clinical studies with health outcomes of medical devices in accordance with applicable FDAAA Section 801 requirements.
- In addition, Amgen voluntarily posts Phase I clinical studies that enroll patients and the protocol governance committee has determined should be registered, as well as post-marketing observational studies that are designed to prospectively evaluate the clinical safety and/or clinical efficacy of an Amgen product as a primary or secondary endpoint, or that are required by a regulatory agency.
Clinical trials are registered no later than 21 days from the first subject enrolled in the study. If Amgen intends to submit the results from a study to an International Committee of Medical Journal Editors (ICMJE) member journal, registration is required prior to the first subject enrolled.
Amgen generally posts technical summary results no later than 12 months after the study ends (primary completion date). For a previously unapproved product or indication, such summary results information is submitted 30 days after regulatory approval in the U.S. In line with the current U.S. laws, Amgen does not post on clinicaltrials.gov technical summary results of products that have been discontinued from further development.
Amgen registers clinical trials and posts results on the EU Clinical Trial Register (EudraCT) .
Amgen-sponsored interventional clinical trials (Phases I-IV) are registered as follows:
- Where there is at least one participating site within the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004
- With a participating site outside the EU/EEA if the trial forms part of a Pediatric Investigation Plan (PIP) or it involves the use of an Amgen medicine in the pediatric population as part of an EU marketing authorization.
To register clinical trials, Amgen provides the participating health authorities with the applicable registration information as part of the Clinical Trial Application. The health authority registers the clinical trial in the EU Clinical Trial Register prior to study start, and this is made publically available (with the exception of adult Phase I trials) once both health authority and ethics committee approvals are completed within the country.
As of July 2015, Amgen has in accordance with the relevant law and guidance submitted summary results to the Register for all interventional trials registered in the EudraCT database within 6 or 12 months from end of trial for pediatric and adult trials respectively regardless of marketing authorization status. The summary results are made publically available (with the exception of adult Phase I trials) by the EMA. Trial results will be submitted (and made publically available by the EMA) retroactively back to 2004 by December 2016 in accordance with transition timelines set forth in regulation and associated guidance.
Post Authorization Safety Studies (PASS)
A post-authorisation safety study (PASS) is carried out after a product has been approved, to learn more about product safety or the effectiveness of risk-management measures. In accordance with Good Pharmacovigilance Practices (GVP) Module VIII, Amgen registers and submits summary results of non-interventional Amgen-sponsored PASS to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) .
- PASS registration is done prior to start of data collection.
- Summary results are generally submitted within 12 months of the end of data collection.