Clinical trials play an important role in the development of new treatment options. Patients can decide voluntarily to take part in them. The studies are subject to a strict quality control plan in order to guarantee the safety of the participants.
To obtain approval for a clinical trial from the European Medicines Agency (EMA) or the Food and Drug Administration (FDA), the results from the preclinical phase must be known. Therefore, the scrutinizing substance is tested in laboratories for possible dangerous effects. After the drug is considered to be safe, it can be given permission to be used in clinical trials. These are divided into three phases, where efficacy and safety of the investigating substance is evaluated in a large number of patients.
Clinical trials involving new drugs are commonly classified into several phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug development process will normally proceed through four phases over many years. If the drug successfully passes through the phases I, II and III it will usually be approved by the national regulatory authority for use within the general population.
Please find further information about ongoing studies on www.clinical-trials.gov, ask your attending doctor or a patient organization in your country / nearby.
For more information about the background and processes of clinical trials, click the following: