Clinical trials play an important role in the development of new treatment opportunities. Patients can decide to participate in such trials voluntarily. In order to guarantee the safety of participating patients, clinical trials are subject to strict quality control guidelines. For a clinical trial to be approved by the European Medicines Agency (EMA) or the Food and Drug Administration (FDA), a new therapy has to establish its safety through preclinical evaluation. This means that the potential treatment is tested for possible dangerous e ects in labs before it is tested in patients. After the drug is deemed safe by the EMA or FDA, it receives permission to enter clinical testing. Clinical trials are divided into three phases that investigate and evaluate the efficacy and safety of the substance in an increasing number of patients.
The drug-development process normally progresses throughout four phases over the course of many years. If the drug successfully passes through the clinical phases (I, II and III) it is typically approved by the national regulatory authority for use in the general population.
For more information about the background and processes of clinical trials, click the following: