We register clinical trials and report clinical study results 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.
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 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 available 30 days after regulatory approval in the U.S.
Amgen registers clinical trials and will post results on the EU Clinical Trial Register (EudraCT) www.clinicaltrialsregister.eu .
Amgen-sponsored interventional clinical trials (Phases I-IV) will be 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.
Beginning July 2015, Amgen will in accordance with the relevant law and guidance post summary results to the Register for all 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 posted (and made publically available by the EMA) retroactively back to 2004 by July 2016 in accordance with transition timelines set forth in regulation and associated guidance.