Clinical Trial Transparency, Data Sharing and Disclosure Practices
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 commit to the PhRMA/EFPIA and IFPMA Principles for Responsible Clinical Trial Data Sharing.
- 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.
Below you can find summaries of our policies effective as of 01 September 2018. For earlier studies, different reporting requirements may have applied.
Amgen’s Clinical Trial Disclosure and Transparency Policies
We register Amgen-sponsored interventional studies on public registries before study start or within 21 days after study start, as follows:
- On clinicaltrials.gov: all phase 2 to phase 4 studies, and most phase 1 studies that enroll patients, conducted anywhere in the world
- On the EU Clinical Trial Register [EudraCT]): all phase 1 to phase 4 studies conducted in Europe. (Phase 1 records are usually not visible to the public)
We register certain Amgen-sponsored non-interventional studies on the EU PAS Register before the start of data collection, including
- post-authorisation safety studies (PASS)
- other non-interventional studies when requested by our protocol governance committees, such as non-interventional studies planned for submission to health authorities in a marketing application
We register expanded access programs at a product level on clinicaltrials.gov. More information is available here.
Results Reporting on Study Registries
We post technical summary results on the registry(ies) where the study was registered. Our current timelines for results reporting are as follows:
- For all studies registered on clinicaltrials.gov with primary completion dates on or after 18 January 2017, results are submitted within 12 to 36 months of the study’s primary completion date.
- For all studies registered on the EU Clinical Trial Register, results are submitted within 12 months of the end of the study (6 months for pediatric studies). Phase 1 study results usually are not visible to the public.
- For non-interventional studies registered on the EU PAS Register, results are normally posted within 12 months of the end of data collection.
We have a longstanding commitment to publication of clinical trial results. 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 are committed to submit clinical trial results for publication regardless of trial outcome or regulatory approval. We submit at least the primary analysis of all completed Amgen-sponsored phase 2 and phase 3 studies to congresses or peer reviewed journals within 18 months of trial completion.
Beyond results of individual clinical trials, we also routinely publish data from observational studies and safety registries that reflect real-world use of Amgen's products, results from integrated- and meta-analyses that permit comparative research, and biomarker studies.
Access to Clinical Trial Data
Amgen shares clinical trial data with external scientific and medical researchers to advance public health. Researchers may request data owned by Amgen from any of its completed clinical trials and observational studies relating to approved uses (eg, indication, dosage form) of products approved in both the US and Europe (or approved in one of the regions if Amgen has determined it will not be submitted for regulatory review in the other region). This policy applies to past as well as future trials.
If you are a qualified researcher interested in collaborating with Amgen and wish to request access to clinical trial data, please click here for information about the process and criteria for data sharing.
To view the latest summary of data sharing requests Amgen has received, click here.
Publication of Clinical Study Reports
Clinical study reports (CSRs) document the methods and results of a clinical trial in detail. Selected CSR main bodies and appendices have been posted to websites operated by the European Medicines Agency (EMA) and Health Canada. External scientific and medical researchers may also request full CSRs under our data sharing process, as described here.
CSR synopses briefly summarize key methods and results of a clinical trial. CSR synopses for many Amgen-sponsored clinical trials are available on www.AmgenTrials.com.
- Synopses for clinical trials submitted in marketing applications for new Amgen products and indications in the US and EU since 2014 are posted within 90 days after regulatory approval in the region with the later approval. For subsequent marketing applications in other countries, synopses for additional studies conducted to support these approvals are posted after the respective approvals.
- Synopses are also available for clinical trials in patients (and for selected non-interventional studies) back to 2004, for approved products and indications or for programs where development has discontinued.
Communicating Research Results to Clinical Trial Participants
Amgen is committed to sharing summary results of clinical trials with the general public, including trial participants. In preparation for new requirements under the EU Clinical Trial Regulation, Amgen is developing plain language summaries of trial results. These will be made available to the public in every language used during the clinical trial. Plain language summaries for selected clinical trials are posted on www.AmgenTrials.com and the Trial Results Summaries portals.
Sharing Clinical Trial Information With Patients and the Medical Community
We bring information about Amgen's clinical trials to patients, investigators, and healthcare communities globally through our website www.amgentrials.com. Contents include:
- Basic information about Amgen clinical trials registered on clinicaltrials.gov
- An investigator survey where medical professionals and investigators can provide a request to be considered on future Amgen clinical trials
- For selected studies, summaries of clinical trial results in scientific language (clinical study report synopses) and/or summaries in plain language (lay summaries)
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.