In compliance with government laws and regulations, a medication must undergo a series of research studies to prove that it is safe and effective for a designated medical condition. After all research is completed, a new drug application is submitted to the Food and Drug Administration (FDA) for review. If the FDA determines that the [...]
Informed consent is a process during which prospective participants and caregivers are told all of the details about the study and receive answers to their questions about how the study will be conducted. Prospective participants and their caregiver or legally authorized representative then sign a written agreement acknowledging that they have been fully informed of [...]
A clinical research study is a supervised evaluation of an investigational medication to determine its safety and effectiveness as a treatment for a specific disease or condition. Individuals enrolled in a study receive an investigational medication and doctors evaluate its safety and effectiveness.
In a study, patients may be divided into two or more groups: [...]