The basics of research
Before any clinical trial can begin, institutional review boards (IRBs) review the trial to ensure that the rights, welfare, and safety of all trial participants will be protected. The FREEDOM-3 trial has been approved by IRBs at all of the trial sites.
During the trial, participants’ health is closely monitored by the study team. If their health gets worse, the study team will decide the safest way to continue, which could include changing to a different medication or leaving the trial completely.
A small group of healthy people are given the investigational therapy to learn about the dose and potential side effects.
A larger group of people with the condition being studied are given the investigational therapy to learn if it could be safe and effective.
The FREEDOM-3 clinical trial is a combination of the above phases (phase 1/2a).
An even larger group of people with the condition being studied are given the investigational therapy to learn if it could be safe and effective, and to compare it against existing treatments (the standard of care) or a placebo (a fake drug).
These trials take place once an investigational therapy has been approved for use. They help us learn how the treatment affects people in the long-term.