A clinical trial is a scientific investigation designed to answer important questions about an intervention, such as:
All investigational drugs must be tested in clinical trials before they may be considered for approval and become available to be prescribed by doctors.
People take part in clinical trials for a number of reasons. For example, they may:
When participating in a clinical trial, it’s important to know:
An investigational drug is not approved by a regulatory authority, as its safety and efficacy have not been established.
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: