What are Clinical Trials?

Clinical trials are research studies that involve people. Carefully conducted clinical trials are the fastest and safest ways to find effective treatments and improve patients’ lives. Many treatments used today to fight cancer and cure disease are the direct result of past clinical trials.

Clinical trials are designed to answer questions about new ways to diagnose and treat cancer or manage side effects from existing treatments. These types of studies may seek to answer questions about new treatment methods or better ways to utilize existing treatments. They may involve testing of new drugs, innovative surgical techniques, or methods for improved delivery of radiation therapy or can include a combination of treatments.

Each clinical trial has specific criteria that patients must meet to be eligible to participate that include age, medical history, previous therapies received and the patient’s current health condition. The criteria for participating are designed to help ensure patient safety along with accurate and meaningful study results.

Clinical trials are conducted in phases – each phase has a specific purpose in helping physicians answer key questions:

Phase 1 Trials help researchers test new or experimental drugs or other treatments in a small group of people to find the best dosage or decide how the new treatment should be given and determine any side effects.

Phase 2 Trials involve a larger group of people to help determine how effective a new treatment is in fighting disease and further evaluate the reactions on the human body. Phase 2 clinical trials focus on evaluating safety and effectiveness of the medication being tested.

Phase 3 Trials involve several hundreds to thousands of people in comparing new treatments or a new use of a treatment with other standard treatments currently in use to fight the disease. Phase 3 clinical trials focus on evaluating the effectiveness and safety of the medication being tested in a large number of people.

Some therapies move on to Phase 4 Trials in order to further assess the long-term safety and effectiveness of new treatments.