The conduct of a clinical trial can determine whether a potential new medicine is safe and efficacious. This is a trial in which people volunteer to receive the new therapy. An observation period then follows, during which the effects are recorded. The set-up and conduct of clinical trials is governed by strict legislation and regulations. Every clinical trial aims to answer specific research questions and will follow protocols established in advance so that accurate and reliable results can be obtained.
The process of bringing a new medicine from the research laboratory to the patient is long and must be 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 this development process is the conduct of clinical trials by physicians. No medicine can be made available to patients without a clinical trial.
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 healthy volunteers. Investigations focus on how the new medicine behaves in the body and what type of administration and 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. Sometimes the decision is made to start this phase 4 trial in order to gain better insight into how the medicine is used in daily practice and what it does over the long term.
Amgen does everything possible to ensure sufficient scientific study opportunities in the Netherlands in all trial phases. Medical specialists and patients thereby get access to new, efficacious medicines. All of these trials meet the same strict requirements, wherever in the world they take place. Do you want to find out more about the scientific trials that Amgen is currently conducting in the Netherlands? You can visit the following website www.clinicaltrials.gov.