Clinical Trial Phases

How New Treatments are Discovered with Clinical Trials

Potential treatments are first tested in the laboratory setting and then on animals before they can be safely tested in clinical trials with people. One of the most important goals of clinical trials is to test the safety of a new treatment; and this must be confirmed in Phase I trials before moving on to Phase II. Usually only 15-30 people (who have no other treatment option) can access a Phase 1 trial where doctors learn more about how safe the treatment is, how it affects the body and how much of the treatment should be offered to fight disease.

After successfully passing the first phase, a potential treatment can progress to Phase II, where about 50-100 people have access. In this phase doctors and patients will learn if the treatment works to cure or manage a particular type of cancer, and if it does this without harming the body. If the treatment looks promising, safe and hopefully effective in fighting cancer, it progresses to Phase III. In Phase III, thousands of people might be able to access the treatment in locations around the country.

Here doctors test how the new treatment compares with standard treatments to determine if the new treatment is better than treatments currently used for a specific cancer.

A Phase III trial aims to show that a treatment is safe and significantly improves the lives of a large number of people (meaning that they live longer or healthier as a result of the drug). If so, the U.S. Federal Food and Drug Administration (the FDA who regulates all phases of clinical trials) will approve the drug for
public use.

Like all drugs, new cancer treatments will have side effects. The benefits of the treatment must be greater than the side effects or risks to patients, in order for a drug to be approved by the FDA. The FDA regulates every step of the clinical trials process to make sure participants are safe. This basic process — from laboratory testing to clinical trials to FDA approval — takes an average of 14 years.

This is a long and expensive process for new cancer treatments, but necessary to ensure that drugs available to the public are safe.

Click here for examples of targeted therapies.

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