Observational Studies

With the help of observational studies, further information on the effects and side effects of the product is researched under less stringent and outpatient conditions. During the clinical trial of phases I to III, the patients who took the drug were practically under constant medical supervision. In addition, the duration of the intake was limited. The number of patients was also ultimately limited. In view of these circumstances, it has proved necessary to continue monitoring beyond release, which will be achieved with far less stringent requirements. These restrict the doctor in his daily practice or put too much strain on him. Rudimentary guidelines are used according to which the therapist recruits his patients and passes on anonymous reports to the pharmaceutical company.