What are clinical trials?

Clinical trials are studies to find better treatments. Is there a safer, more effective, less harmful remedy? Are there better detection methods or markers? Could something be changed to prevent a disease? Are there better ways of supporting a patient's quality of life?

To find the answer, researchers plan a study and structure it to make the results clearer. A study has guidelines, for example, limiting it to a certain disease. In the case of cancer, staging would be another factor. Age, gender and health of a patient are usually included in study guidelines.

Studies for new drug therapies are divided into stages, called phases.

• Phase I studies are commonly called "first in man." Cancer patients who enroll in these trials have already tried other treatment options. These studies evaluate the dose of a drug that can be given safely without unacceptable side effects and how the drug affects the body. They involve a small number of patients with cancer.
• Phase II studies continue to study the safety of a drug and also determine how well the drug works in a specific type of cancer. These studies typically enroll fewer than a hundred patients.
• Phase III studies focus on how well the drug works compared with other current treatment methods. These studies enroll hundreds to thousands of patients.
• Phase IV studies enroll thousands of people over a longer period of time, compared with the earlier Phase I, II or III studies. These studies occur after a drug has been approved by the Food and Drug Administration and gather long-term safety information and therapeutic effectiveness.

Learn more about how clinical trials are managed at MCG and what clinical trials are open now.