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Subject:phases of trials

What is the best phase to enter a trial? Also, do you have to be at MD Anderson to participate in their trials?

Posted: 26 Sep 2005 04:30 PM
Originally Posted: 26 Sep 2005 11:33 AM
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Total Messages 63

Subject:phases of trials

Thank you for contacting the University of Texas M. D. Anderson Cancer Center concerning clinical trials.

There are four phases to clinical trials. There is not a phase that would be considered the best, but there are benefits of each. If a patient is interested in very new drugs that are in early testing, they might want to look for a phase I trial. If a patient is interested in a drug that has been more established, they might want to search for a later phase. Each phase is an important step in determining whether a new investigational drug is beneficial.

The phases are as follows:

Phase I trials involve a small number of people to test a new treatment that has already undergone rigorous testing on animals. In cancer
studies, participants usually have advanced cancer that hasnt responded to standard treatments. At this stage, researchers can only predict outcomes and any possible side effects on humans. During Phase I trials, investigators determine the most effective dosage and application methods. One of the benefits of participating in a Phase I treatment trial is the opportunity to be among the first to receive a new treatment that might prove effective against cancer. Although the effectiveness of the treatment at this stage has not been demonstrated, some cancer patients have seen improvement in Phase I trials.

Phase II trials involve a larger group of patients and allow researchers to build on what they learned in Phase I. Because more subjects are involved, investigators may discover less common side effects, and will continue to evaluate the safety of the treatment.

Phase III trials may involve over a thousand patients, often at several medical institutions. During this phase, the study treatment is compared to and/or combined with standard modalities (treatment methods). Some participants, the "treatment group," are given the experimental treatment, and others in a "control group" are given the current standard treatment, so researchers can compare outcomes. Placebos are rarely used during Phase III trials. Researchers instead try to find out if the new treatment works better than, the same as, or worse than the standard treatment in participants ranging from newly diagnosed patients to people with advanced disease.

Phase IV trials occur after the treatment has been put on the market to monitor effects of long-term usage and how it affects certain population groups. If dangerous side effects are found, the drug or treatment is taken off the market.

To answer your second question, to participate in any of our clinical trials, you would have to be a patient here. You can review the clinical trials that we are currently offering by going to
- click on "Clinical Trials at M. D. Anderson"
- click on "View studies by cancer type"
- choose the cancer type

When you click on a particular clinical trial, the study summary will show the inclusion and exclusion criteria, as well as whether or not the study is currently enrolling new patients. The study summaries can be detailed and it may be beneficial for you to print them and review the material with your doctor.

The National Cancer Institute is also an excellent resource on all types of cancer, as well as having information about clinical trials going on throughout the United States. Their web address is you can call toll-free at (800) 422-6237.

I hope that this information is helpful. If you would like any additional information about M. D. Anderson services, programs, or appointment information, do not hesitate to contact the M. D. Anderson Information Line at 1-800-392-1611, option 3.

Posted: 27 Sep 2005 11:57 AM
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