A clinical trial is a research study in which people participate, to prove or disprove the effectiveness and safety of a new medical treatment, drug or device. Every research study must follow a plan called a "protocol". The protocol outlines the entire study, including the purpose and all procedures to be followed by the researcher(s).
Typically, there are four phases of clinical trials:
Phase I trial: An experimental drug, device, or treatment is tested on a small group of people, usually with 20 to 80 participants. The purpose of a Phase I trial is to determine the safety of the treatment, device or drug.
Phase II trial: Further study of new drug, device, or treatment with 100 to 300 participants, who have the condition or disease that is the target of the treatment. A Phase II trial is designed to determine 1) if the drug or device is an effective treatment for a specific disease, 2) has any side effects.
Phase III trial: Large groups of people (1,000 to 3,000) participate to allow researchers to collect data on safety and effectiveness of a drug or treatment and to compare the new treatment to the standard treatment or to placebo. Placebo is an inactive treatment used to compare the effects of the experimental treatment with no treatment.
Phase IV trial: A study to further determine the risks, benefits, and best use of the drug or treatment once the treatment is approved by the FDA and on the market. Usually thousands of people are involved in this phase of the trial.
Clinical trials are only permitted if volunteers understand the risks associated with each study and decide to participate without feeling pressured. The rights and welfare of research participants are protected by the Wentworth-Douglass Hospital Institutional Review Board. The Institutional Review Board may be reached at 603-740-3255.