Amgen aims to discover, develop, and deliver transformative medicines to address some of the leading causes of death and disability worldwide, working to meet the needs of as many patients as possible. Conducting our research and development activities in accordance with our internal policies and external standards helps to ensure the integrity of and confidence in our trial results and, ultimately, in medicines approved for use. It also helps inspire confidence among potential clinical trial participants, increasing the likelihood of their enrollment in studies.
Clinical Research and Development
The rights, dignity, safety, and well-being of clinical trial participants are critical to the effective conduct of Amgen clinical trials. To that end, our Global Code of Ethics governs the design and conduct of Amgen-sponsored trials. Our high standards meet or exceed applicable local laws as well as widely accepted international regulatory standards.
Use of Animals in Research
We are committed to the ethical and responsible treatment of animals required be used in the discovery and development of our medicines. Amgen is a long-time proponent of the principles of Reduction, Refinement, and Replacement ("the 3 Rs") in the required use of animals in research. Amgen is fully committed to the development and use of scientifically validated alternative testing methods that are acceptable to regulatory authorities and do not compromise patient safety. We are engaged internally and in cross-industry efforts aimed at developing and refining new in-vitro testing and predictive systems that hold promise for future reduction of animal usage. As part of these activities, Amgen works directly with global regulatory authorities to increase the recognition and acceptance of alternative models where such methods can be used appropriately.
Amgen works to comply with all applicable global laws and regulations, including the gold standards of accrediting bodies. We hold our external business partners, including contract research organizations, academic institutions, and animal vendors, accountable to the same regulations, standards, and guidelines that govern our internal animal care and use programs. We have a robust, proactive process to monitor their compliance with our standards. In 2021, we updated our Commitment to the Ethical Use of Animals in Research policy statement to make our oversight process more transparent. Read more in our Commitment to the Ethical Use of Animals in Research.
Use of Stem Cells
Amgen is committed to the ethical use of stem cells in research to help unlock new scientific insights, model complex diseases, screen new compounds, and identify novel medicines. Read more in our Position Statement on Stem Cell Research.
Biobanking of Human Samples
Human samples play a vital role in Amgen's research, including helping to predict the safety and effectiveness of potential new therapies and identify people most or least likely to benefit from these therapies.