×

Do you want to link to this External Site and leave Amgen.com?

YOU ARE NOW LEAVING AMGEN'S WEB SITE. Amgen takes no responsibility for, and exercises no control over, the organizations, views, or accuracy of the information contained on this server or site.

×

Do you want to link to this External Site and leave Amgen.com?

YOU ARE NOW LEAVING AMGEN'S WEB SITE. Amgen takes no responsibility for, and exercises no control over, the organizations, views, or accuracy of the information contained on this server or site.

×

Do you want to link to this External Site and leave Amgen.com?

YOU ARE NOW LEAVING AMGEN'S WEB SITE. Amgen takes no responsibility for, and exercises no control over, the organizations, views, or accuracy of the information contained on this server or site.

×

Do you want to link to this External Site and leave Amgen.com?

YOU ARE NOW LEAVING AMGEN'S WEB SITE. Amgen takes no responsibility for, and exercises no control over, the organizations, views, or accuracy of the information contained on this server or site.

Clinical Trial Transparency, Data Sharing and Disclosure Practices

 

"With a 35-year history as an innovator of breakthrough medicines for grievous illnesses, Amgen has established a strong partnership with the scientific and healthcare community built on the principles of scientific exchange and a shared desire to improve patients' lives. As such, we are committed to disclosing publicly the findings from our clinical trials, recognizing that these disclosures contribute to the overall understanding of the benefit-risk profiles of Amgen's medicines and empower patients and physicians to make informed decisions about what's best for the patients in terms of treatment options."

Paul Eisenberg
SVP, Global Medical and Chief Medical Officer

 

Clinical data transparency is an important issue for Amgen.

  • We aim to ensure that our research practices are transparent, responsible, and fully compliant with applicable laws, regulations and guidelines.
  • We have dedicated and trained staff for purposes of timely registration of clinical trials, communication of research results, and publication of Amgen-sponsored trials and observational studies.
  • We collaborate with external medical and scientific researchers to advance clinical research and enhance public health.

Sharing Clinical Trial Summary Results With Patients and the Medical Community

Additional information about Amgen’s clinical data transparency initiatives can be found here:

Information About Amgen-Sponsored Clinical Trials

Read More

We are dedicated to bringing information about Amgen's clinical trials to patients and healthcare communities globally through our website www.amgentrials.com .

  • Patients and investigators can view all Amgen-sponsored clinical trials by visiting www.amgentrials.com .
  • The website also has an investigator survey where medical professionals and investigators can provide a request to be considered on future Amgen clinical trials.

If you would like information about becoming an investigator for an Amgen-sponsored trial, please click here.

Other inquiries about Amgen products can be addressed through Medical Information at www.amgenmedinfo.com .

To report an adverse event or product complaint, all individuals should contact a Medical Information Healthcare Professional directly at 1-800-77-AMGEN.


Registration of Clinical Study Information and Results Reporting

Read More

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.

In Europe:

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.

Publication Practices

Read More

Amgen is committed to the highest scientific and ethical standards for publications and is dedicated to providing scientifically accurate, fair, and well-balanced publications to the scientific community.

  • We publish results of Amgen-sponsored trials (primarily Phase 2 and 3 clinical trials and observational studies) in peer-reviewed scientific congresses and/or journals, regardless of study outcome and regulatory approval.
  • We are committed to submitting publications within 12 months of study completion.
  • We publish data beyond individual clinical trial results, including data from observational studies and safety registries that reflect real-world effectiveness of Amgen's products, results from integrated- and meta-analyses that permit comparative research, and biomarker studies that enable individualized patient care.

Amgen has consistently published trial results even if the data were not favorable, if the clinical program was discontinued, or if results failed to garner regulatory approvals for a specific indication.

Access to Clinical Trial Data

Read More

Amgen takes a collaborative approach to data sharing with external scientific and medical researchers and supports advancing public health through further clinical research of our clinical trial data. 

We have an established process for the review of research proposals received from qualified external medical and scientific researchers. The process for requesting Amgen clinical data includes submission of a data sharing request to Amgen via datasharing@amgen.com. Research proposals are then reviewed by a committee of internal advisors and, where necessary, a Data Sharing Independent Review Panel (DSIRP). The following individuals form the DSIRP:

  • V. Michael Holers, M.D.
    Head, Division of Rheumatology,
    Scoville Professor of Rheumatology,
    Professor of Medicine and Immunology,
    University of Colorado School of Medicine

     
  • Steven Piantadosi, M.D., Ph.D.
    Phase One Foundation Chair
    Director at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Amgen shares data directly with researchers through a data sharing agreement. If you are a medical or scientific researcher interested in collaborating with Amgen and wish to request access to clinical trial data, please click here for information about the criteria, process and method for submitting a data sharing request.

Other inquiries about Amgen products can be addressed through Medical Information at www.amgenmedinfo.com .

Publication of Clinical Study Reports

Read More

Clinical Study Reports (CSRs) are used to document the safety and efficacy (outcome) of a clinical trial as well as the trial methods and results.

In addition to sharing technical results summaries on clinicaltrials.gov and the EU Clinical Trials Register (EudraCT), Amgen has committed to publicly disclose a synopsis of each clinical study report for Amgen-sponsored trials included in the marketing application beginning with new product approvals in 2015. For new products filed in the U.S. and EU after January 1, 2014, CSR synopses will be posted publicly within a reasonable time after regulatory approval in the later region.

In 2015 Amgen is beginning a process to be completed in 2017 to make clinical results data more readily available. The plans include publicly sharing available CSR synopses retrospectively to 2004 and creating a 'one-stop-shop' inventory of studies and CSR synopses on an Amgen dedicated portal.

Full clinical study reports will be made available for those studies included in an approved data sharing request submitted by external scientific and medical researchers interested in collaborating with Amgen.

Beginning in 2015, main body CSRs will be publicly available upon marketing authorization by the European Medicines Agency (EMA) for all new products submitted after Jan. 1, 2015, and new indications submitted after July 1, 2015.

To locate the CSR synopsis for a particular Amgen-sponsored trial approved since 2015, please click here.

Communicating Research Results to Clinical Trial Participants

Read More

Amgen is currently developing a process to share lay summaries of clinical study data in Amgen-sponsored trials with clinical trial participants. Lay summaries will be made available pending guidance from regulatory agencies in accordance with our commitments under the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing as well as requirements under EU regulation.

  • Patients and investigators can view all Amgen-sponsored clinical trials by visiting www.amgentrials.com .
  • The website also has an investigator survey where medical professionals and investigators can provide a request to be considered on future Amgen clinical trials.

If you would like information about becoming an investigator for an Amgen-sponsored trial, please click here.

Other inquiries about Amgen products can be addressed through Medical Information at www.amgenmedinfo.com .

To report an adverse event or product complaint, all individuals should contact a Medical Information Healthcare Professional directly at 1-800-77-AMGEN.

We are dedicated to bringing information about Amgen's clinical trials to patients and healthcare communities globally through our website www.amgentrials.com .