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Clinical Trials: A Guide for Patients

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

Applied Research Starts in the Laboratory

Clinical trials make it possible to apply the latest scientific and technological advances to patient care.

During a clinical trial, physicians use the best available treatment as a standard to evaluate new treatments. The new treatments are considered to be at least as effective or possibly more effective than the standard.

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

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

Is the treatment safe and effective?
Is the treatment potentially better than the treatments currently available?
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 phases.

What Are the Different Phases of a Clinical Trial?

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

Phase II clinical trials determine the effect of a research treatment on the particular disease or special condition being evaluated.

Phase III clinical trials compare the new treatment with the standard treatment.

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

Advantages and Side Effects

The advantages of participating in a clinical trial include the following:

You may receive a new treatment before it is widely available to the public.
You can provide researchers with the information they need to continue developing new procedures and introducing new treatment methods.
Your treatment costs may be decreased, since many of the tests and physician visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. Be sure to discuss your treatment costs with the physicians and nurses conducting the clinical trial.