A clinical trial is the final step of a research study on a new treatment that has already been successfully tested in laboratory animals and is ready to be tried on humans. It is designed to answer specific questions about a new drug or treatment, such as, do more patients survive after receiving the new drug than after getting traditional therapy? Are there fewer side effects with the new drug than with the standard therapy drugs?

These and other important questions must be answered before the FDA (Food and Drug Administration) can approve a new treatment for general use.

Patients must volunteer to take part in a clinical trial. However, they usually will not be told whether they are in the "study group" that receives the new treatment or in the "control group" that receives the standard treatment or a placebo (sugar pill). But patients who take part in clinical trials could be some of the first people to benefit from a new treatment.

Each patient who desires to participate must meet strict eligibility criteria for the particular study before he/she can be included. The patient’s physician will review the patient’s medical history, cancer diagnosis, and other specific cancer information to evaluate whether the patient may participate.

There are many different types of clinical trials, but all of them are tested in three phases:

• Phase I trials are run on a small number of people (perhaps as few as a dozen). They are designed to determine the specifics about administering a drug: how it should be given (IV, by mouth, etc.), how often it should be given, and what dose would be safe to use.



• Phase II trials measure how effective the drug is for its intended purpose. For example, does the drug cause a tumor to shrink in size?



• Phase III trials compare the effectiveness of the new drug against the standard therapy. For example, does the new drug cause a tumor to shrink in size more than it would if it were treated with standard drugs? Phase III trials usually involve a large number of patients who are randomly assigned to either the study group or the control group.

• National Cancer Institute clinical trials web page at http://www.cancer.gov/clinicaltrials.
• The Cancer Information Service (CIS) at http://cis.nci.nih.gov, or call 1-800-4-CANCER.
• ClinicalTrials.gov, a registry developed at the National Institutes of Health (NIH) by the National Library of Medicine at http://clinicaltrials.gov.
• American Cancer Society at http://clinicaltrials.cancer.org/ or 1-800-ACS-2345.
• Lance Armstrong Foundation clinical trials at http://www.livestrong.org/clinicaltrials or call 800-620-6167.
• CenterWatch Clinical Trials Listing Service at http://www.centerwatch.com.