Clinical trials Flashcards
Clinical phases
Phase I: In this phase, a small group of healthy volunteers is given the new drug or treatment. The purpose of this phase is to determine the safety, dosage, and potential side effects of the treatment. Phase I trials usually involve 20-100 participants.
Phase II: In this phase, a larger group of patients who have the disease or condition being studied are given the treatment. The purpose of this phase is to evaluate the efficacy of the treatment and to continue to monitor its safety. Phase II trials usually involve several hundred participants.
Phase III: In this phase, the treatment is given to an even larger group of patients. The purpose of this phase is to confirm the effectiveness of the treatment and to compare it with standard treatments or a placebo. Phase III trials usually involve thousands of participants.
Phase IV: After a treatment has been approved by regulatory agencies and made available to the public, phase IV trials are conducted to continue to monitor its safety and effectiveness in a larger population over a longer period of time. These trials are also used to gather additional information about the treatment, such as its optimal use and potential long-term effects.
