Clinical Trials

Clinical trials to evaluate new ways to treat cancer are an appropriate option for many people with colorectal cancer. By participating in clinical trials, you may gain access to new treatments not available elsewhere and care by some of the countries best doctors.

What Is a Clinical Trial?

A clinical trial is a research program conducted in patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating diseases and conditions.

Clinical trials make it possible to apply the latest scientific and technological advances to patient care. During a clinical trial, doctors use the best available treatment as a standard of comparison for evaluating the new treatments. The new treatments are hoped to be at least as effective or possibly more effective than the standard treatment.

New treatment options are researched first in the laboratory where they are carefully studied in the test tube and then in animals. Only those treatments most likely to work are further evaluated in a small group of people, prior to applying them in a larger clinical trial.

When a new medical treatment is studied for the first time in people, it is not known exactly how it will work. With any new treatment, there are possible risks as well as potential benefits. Clinical trials help doctors discover the answers to the following questions:

• Is the treatment safe and effective?
• Is the treatment better than the currently available treatments?
• What are the side effects of the treatment?
• Does the treatment have any possible risks?
• How well does the treatment work?

Phases of a Clinical Trial

Clinical trials are conducted in phases, each designed to find out specific information. Each new phase of a clinical trial builds on information from previous stages.

Participants may be eligible for clinical trials in different phases, depending on their overall condition. Most clinical trial participants take part in Phases III and IV.

What are the Different Phases of a Clinical Trial?

In a Phase I clinical trial, researchers give the new treatment to a small number of patients to determine the best way to give it and how much can be given safely.

In a Phase II clinical trial, researchers determine the effect of a treatment on the particular disease or condition being evaluated.

In a Phase III clinical trial, researchers compare the new treatment with the standard treatment.

In a Phase IV clinical trial, researchers apply the new treatment to general patient care. For example, a new drug that was found effective in a clinical trial may be used together with other effective drugs to treat the particular disease or condition in a select group of patients.