About Clinical Studies
What Are Clinical Studies?
- Test to see if investigational drugs are safe and if they work
- Involve collecting information from study tests and procedures to answer certain questions
- May or may not directly benefit the participant, but the study results may help patients in the future
- Are voluntary, so it is up to the participant to decide if he or she wants to be in a clinical study
- Have to be reviewed and approved by an Institutional Review Board
What Is an Investigational Drug?
- A substance that is tested in clinical studies to see if it works and is safe before it can be approved by the US FDA to be prescribed by a doctor
What Is an Institutional Review Board (IRB)?
- A group of people that reviews and monitors the clinical study to protect the rights and welfare of the study participants
What Is an Extension Study?
- Extension studies like Encore help doctors continue to learn about the long-term safety and effectiveness of study drugs like ADP101.