What is the Clinical Trial Process?

There are three phases that an investigational drug must go through successfully in order to be approved by the FDA. Following approval there is a fourth phase which drugs may enter for continued testing.

Phase I

These are the first trials of a medication in humans, and are usually performed in healthy volunteers in an inpatient facility to establish guidance for dosing of the medication in further trials. At Coastal Connecticut Research we do not participate in this phase of development.

Phase II

A drug becomes eligible for Phase II trials only when the FDA has reviewed Phase I data and has concluded that it is safe to be used in humans under the controlled conditions of an investigational trial, and that it may potentially be beneficial to patients with a particular disease. This is often the phase in which a pharmaceutical company hopes to decide whether it will be worthwhile continuing development of a particular drug, or whether it is worthwhile pursuing new indications for a drug that has already been approved for a different purpose. Typically about 50-200 patients will receive the investigational drug in this phase of testing. This number may be considerably higher if the drug is being tested for multiple possible indications. These trials usually also have a second group of patients called the "control" who receive either a standard treatment or a placebo. Patients are assigned to either the treatment group or the control group at random, and neither the physician nor the patient is aware of which group the patient is in.

Phase III

A drug enters Phase III if the pharmaceutical company is satisfied that there is a reasonable likelihood that it will be beneficial for its intended purpose and if the FDA is satisfied with the safety and efficacy data obtained in the Phase II trials. These trials involve a greater number of patients than the Phase II trials, and are usually conducted at many different research sites simultaneously. Several hundred to several thousand patients are involved in this phase of medication development, and there is a control group in these studies as in Phase II. Most drugs that enter this phase of testing will at least be considered for approval by the FDA, though not all of them will ultimately be granted approval.

Phase IV

These trials are conducted on medications that have already been approved for use by the FDA, and that are on the market. Additional safety data is obtained in this phase of testing, and these trials are often used to assess the effects of treatment on a patient’s general quality of life as well as on the specific disease being treated. These trials may also compare a drug with other drugs or treatments already on the market.

At Coastal Connecticut Research we participate in Phase II through Phase IV trials. All of these trials have been designed by the sponsoring pharmaceutical company and have been approved by both the FDA and an Institutional Review Board (IRB).