A clinical research study is a scientific investigation designed to answer important questions about an investigational drug, such as:
All investigational drugs must be tested in clinical research studies before they are approved and available to be prescribed by doctors.
People take part in clinical studies for a number of reasons. For example, they may:
When participating in a clinical research study, it’s important to know:
Even before a study starts, safety is our highest priority. Every study must be reviewed and monitored by either an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC). These groups, which are made up of both scientists and non-scientists, review the study’s plan to make sure that: