Phases of Research Research studies are generally divided into
four phases: Phase I trials are designed to confirm the safety
of a new medication. Phase I trials generally involve a small
group of healthy volunteers and typically last three to four
months. Phase II trials help to confirm whether or not a
medication is effective. These studies are “randomized”.
Randomization means that participants are divided into two
groups—one group receives the active treatment and the other
group receives a “control”. (Usually the standard treatment
available). Phase III trials are initiated once a treatment has
demonstrated both safety and efficacy. Phase III trials help
determine whether a medication is effective over a longer period
of time. These trials are longer and larger, in terms of the
number of participants. Phase III trials can provide enough data
for a product to be submitted for approval by the Food and Drug
Administration (FDA). Phase IV clinical trials are conducted to
obtain more information on a new medi