Phases

Clinical research that involves testing a novel drug or new delivery method takes place in phases. Each phase allows researchers to address questions and answers in a way that garners reliable data about the drug being tested. Each phase provides important information about the efficacy and safety of the drug being tested.

Phase I trials help determine the safety of a new drug. The goal is to determine the safest dose of a drug that can be given without creating harmful side effects to patients. The best delivery method is also determined during a Phase I trial (oral or intravenously). These trials typically include a small number of patients.

Phase II trials continue to determine the safety and the effectiveness of how well a drug works. These trials typically focus on a certain type of cancer, and include less than 100 people. If this new treatment shows effectiveness against cancer by a certain percentage of patients responding to the treatment, it may be considered to continue on to a Phase III clinical trial.

Phase III trials determine whether the new treatment is better than the current standard treatment for a particular type of cancer. A participant is randomly assigned to the standard therapy or to the new treatment method being tested. These trials often enroll large numbers of patients are conducted at multiple cancer centers across the country.

Neither the patient nor the physician is able to choose whether the patient is in the control group or the experimental group. When a patient participates in a Phase III clinical trial, they will receive the best standard treatment available or the new treatment that physicians believe is as good as or better than the standard treatment for their type of cancer.