Clinical research studies are conducted to determine whether an investigational medicine is safe and effective in treating a particular disease. ‘Investigational’ means that the medicine has not been approved for a particular clinical use and is still being evaluated in studies such as the one described below. All investigational medicines must go through several phases of clinical research before they are approved. Clinical research studies also check for any side effects that may develop while taking the investigational medicine.
Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help ensure that patients’ rights are protected while information about the investigational medicine is collected. Once these studies are completed, government agencies review the information then decide whether the investigational medicine should be made available for public use.