What is
clinical research?
Clinical research is the process by which pharmaceutical companies and research institutions investigate new medications for the many diseases that exist. It is a process that helps scientists and doctors learn about different conditions and about how potential new medications (called investigational medications) affect people.
If you’re living with ATTR amyloidosis,
a
clinical research study may be right for you.
Clinical research studies, also called clinical trials, are used to evaluate medicines to make sure they are safe and effective.
In order for a medicine to become approved to treat or prevent a disease, it must first undergo clinical research.
Clinical research studies happen in 4 phases:
Phase 1
Checks the safety and dosing of the investigational medication. About 20-100 people are evaluated. Sometimes healthy volunteers are included.
Phase 2
Checks the safety and effectiveness of the investigational medication. About 100-200 people with the condition are evaluated.
Phase 3
Checks for health benefits and health changes or problems that may occur. About 300-3000 people with the condition are evaluated.
Phase 4
Checks for long-term effects after the medication is approved. Any number of people taking the approved medication are evaluated.