A clinical trial is conducted to collect data regarding the safety and efficacy of a
new drug and/or device that is either in development, or already FDA approved
but not for the indication being studied.
There are several steps and stages of approval in the clinical trials process
before a drug or device can be sold in the consumer market. Drug and device
testing begins with extensive laboratory research which can involve years of
experiments in animals and human cells. If the initial laboratory research is
successful, researchers send the data to the Food and Drug Administration
(FDA) for approval to continue research and testing in humans.
Once approved, human testing of experimental drugs and devices can begin
and is typically conducted in four phases. Each phase is considered a separate
trial and, after completion of a phase, investigators are required to submit their
data for approval from the FDA before continuing to the next phase.