About Clinical Trials

What is a clinical trial?

Melanoma clinical trials are research studies involving human volunteers that are designed to answer specific questions about new treatments for melanoma. The answers gained through the research helps doctors find new ways to improve outcomes for people with melanoma.

Researchers use clinical trials to test new treatments or a new combination of existing treatments. The treatments under study in clinical trials have already undergone rigorous testing to minimize any safety risks for patients. The goal of a clinical trial is to determine whether a new therapy improves a patient’s outcome, makes no difference, or causes potential harm. Researchers also use the information from clinical trials to determine dosage amounts and treatment schedules and to evaluate side effects.

All treatments and medications currently available, first went through clinical trials. Clinical trials for melanoma are designed to treat melanoma, find and diagnose melanoma, prevent melanoma, and manage symptoms related to melanoma and melanoma treatments. This long, careful process provides the best possible data for government approval and widespread use of safe, effective treatments.

Clinical trials test (i.e. trial) treatments or methods that have not yet been approved by the United States Food and Drug Administration (FDA). Joining a clinical trial is a viable treatment option for people with melanoma, and all cancers, and participation often represents patients’ best access to cutting-edge research.

When making treatment decisions, patients should consider all their treatment options, including clinical trials. Some people think that clinical trials are only for late-stage disease or should only be considered after undergoing treatments that are currently approved, but that is only a myth.

How do clinical trials work?

Experimental treatments are first evaluated in a series of preclinical studies. If these preliminary tests indicate that a new treatment is generally safe and works as intended, researchers request approval from the FDA (or similar organizations around the world) to move forward with more advanced testing in a clinical trial.

A treatment must go through a clinical trial before the FDA will consider approving it for public use. Generally, this involves three phases of testing. All phases focus on evaluating the treatment’s effectiveness and safety and identifying side effects.

The three phases of clinical trials are:

• Phase I: Researchers conduct first-time testing of a treatment on patients. The goal is to determine safe dosage amounts, evaluate the safety of the treatment, identify side effects, and evaluate early evidence of effectiveness.
• Phase II: This phase expands the drug or treatment testing to a larger group of people often at the dose (or doses) that appears most promising from the first phase. Researchers continue to check for safety and side effects, but the focus of a phase II study is to determine whether the treatment works.
• Phase III: The trial now expands to include hundreds, sometimes thousands, of patients. Some clinical trial participants receive the new, or experimental, treatment either alone or in combination with the standard therapy. Others may get the standard therapy by itself. The goal is to collect data on the treatment’s effectiveness, safety, and side effects. Companies use this information when requesting regulatory approval from government agencies like the FDA.

All trials begin in Phase 1. If Phase I is successful, then the research may proceed to the next phase, or if the results are particularly compelling, a new treatment may jump directly to Phase III testing.