Purpose

This Policy sets forth Amgen’s Code of Ethics for clinical trials.

Scope

This Code of Ethics applies globally to all Amgen clinical trial activities.

Policy

Amgen’s mission is to serve patients and its clinical trial activities are carefully designed to meet this aspiration. Amgen strives to maintain high ethical principles, as well as high scientific and clinical standards in all of its clinical trials regardless of where they take place. The rights, dignity, safety and well being of research participants are paramount in conducting Amgen clinical trials. To that end, all Amgen sponsored trials are designed and conducted to the same high standards that meet or exceed all applicable local laws as well as widely accepted international regulatory standards. Amgen maintains detailed internal procedures to ensure compliance with these laws. Amgen’s procedures cover:

Appropriateness: All Amgen research will be designed to answer clearly defined questions. Amgen will prospectively evaluate its research programs to ensure that the potential benefit to the patient and society is in proportion to the inherent risk and burden to the research participants.

Selection of Investigators: Clinical investigators will be selected based on qualifications, training, research, and/or clinical expertise in relevant fields, the potential to recruit research participants, and the ability to conduct clinical trials consistent with this Policy. The independence of clinical investigators and others involved in clinical research will be respected so they can protect research participants’ best interest.

Ethical Review: Amgen sponsored trials will undergo an ethical review, as required, by a qualified independent committee (Institutional Review Board/Independent Ethics Committee) prior to trial initiation.

Privacy: Amgen is committed to protecting research participants’ privacy and complying with all applicable privacy laws. Amgen will require that its agents are contractually obligated to do the same.

Informed Consent: Amgen will obtain voluntary informed consent from all research participants where required prior to carrying out any protocol specified procedures. Informed consent will outline the known benefits and risks of participating in the trial. Amgen’s process for obtaining informed consent will take into account local law, language and custom as well as the patient’s ability to understand the information presented. Amgen will take additional steps to ensure appropriate informed consent for vulnerable research participants, such as minors.

Safety Monitoring: Amgen will ensure that adverse event information regarding its products is collected, processed, reported, analyzed and communicated. Amgen will continuously monitor the safety of its investigational therapies by ensuring clinical investigators appropriately report adverse event information and appropriately update research participants of any new risks associated with the use of the trial drug that arise during the course of the clinical trial.

Standard of Care: Amgen will set up and monitor its clinical trials to ensure the rights and well being of research participants are protected. The standard of care provided to control groups will be, at a minimum, equivalent to well-established and commonly employed local treatment. Amgen will engage in placebo-controlled trials only when there is genuine uncertainty as to the therapeutic merits of the proposed treatments under trial.

Continued Access: To serve patients, Amgen engages in clinical research with the goal of obtaining regulatory approval of its products. Regulatory approval ensures that the benefits of new therapies are available to the broader patient population. Under certain limited circumstances, Amgen may provide continued access to investigational drug to research participants once a trial is completed. This access will balance the need to treat seriously ill patients who cannot be satisfactorily treated with commercially available product with the goal of providing access to the product via the regulatory approval process.

Compensation: Amgen payments to research participants will be appropriate based on the local economy and will be evaluated as part of the ethical review. Amgen will provide locally appropriate compensation for injuries, which will be disclosed to patients as part of the informed consent process. Amgen payments to clinical investigators will be reasonable and based on their work.

Transparency: Amgen posts protocol information regarding ongoing phase II, III, and IV interventional clinical trials on the www.clinicaltrials.gov and the www.amgentrials.com websites. Amgen also posts summaries of clinical trial results for these phases of interventional research for our marketed products.

Amgen’s Code of Ethics for Clinical Trials is posted here for potential clinical investigators and potential research participants to review prior to committing to participate in an Amgen trial.

For more information about Amgen’s clinical trials, click here.