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When people are impacted by disease, they deserve the best treatment. Unfortunately, there are still no effective treatments for all. Thanks to continuous new discoveries in biological processes and data science, we learn more every day about how to successfully develop and make revolutionary medicines available. In order to determine and study the optimal efficacy of the medicines, clinical research is necessary, and Amgen is conducting it worldwide, including in the Netherlands.
The process of bringing a new medicine from the research laboratory to the patient is long and careful. Long, because it takes an average of around 12 years to complete all laboratory, animal experimental and human tests and for the medicine to be made available. Careful, because many strict requirements must be met in order to guarantee patient safety.
One of the most important steps in the development process is the conduct of clinical trials, studies with people who voluntarily received the drug and are observed for its effects. Through these studies, medicines are tested to determine whether people benefit from them. But before this can happen, people must volunteer and participate – a choice that can benefit not only the person themselves, but many others as well.
Whether or not you are eligible for a clinical trial depends on a number of factors, including your medical condition. Your doctor will discuss these factors with you and provide you with comprehensive information about the investigational medicine and the study itself.
Amgen carries out trials in the Netherlands in many different areas. Clinical trials are divided into four phases:
Phase 1: A new medicine is administered for the first time to a small group of volunteers. Investigations focus on how the new medicine behaves in the body and what type of administration/dosage is most appropriate.Phase 2: Administration to a small group of patients. Investigations focus on whether the medicine works well for the intended illness. The optimal dosage is also sought.
Once phase 1 and 2 have been completed successfully, the new medicine can be investigated in large groups of patients.
Phase 3: Extensive trial involving large numbers of patients. Efficacy in relation to existing medicines and/or in relation to a placebo (fake medicine) is investigated.
In all trial phases, a great deal of attention is paid to the identification of side effects.
Phase 4: This is an observational trial, conducted after approval for the medicine has been obtained, on the basis of the data from phase 1-3 investigations. Phase 4 research is being started to gain better insight into the use of the medicine in daily practice and its long-term use.
Amgen does everything possible to ensure sufficient study opportunities in the Netherlands in all trial phases. All these studies meet the same strict requirements, no matter where in the world they take place. Click on the link below to learn more about ongoing Amgen studies in the Netherlands or visit www.clinicaltrials.gov.