What is a Clinical Study?
A clinical study is carefully designed to test the effects of a medication, medical treatment,
or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure
the drug's ability to treat a condition, its safety and its possible side effects.
Who Can Be in a Clinical Study?
People with the condition being studied as well as healthy people can volunteer to participate
in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve
patients with the conidtion being studied.
Who is the Institutional Review Board (IRB)?
The IRB is a group of healthcare professionals and members of the local community which must
review and approve a clinical study before it begins. The IRB carefully reviews study activities to protect the safety and
rights of study participants.