77 New Clinical Trials Announced in September, 2004

Be sure to check this site for monthly updates on recently announced clinical trials.

Many of us view clinical trials as the use of human guinea pigs in medical experimentation with more for harm than good. The reality is that far more people are helped than hurt by U.S. clinical trials, and all participants must by fully informed of their prospects and risks.

Clinical trials in this country are divided into three phases:

Phase I.

In this first phase, drugs (or other treatments) that have been comprehensively tested on animals are first administered to humans. Because the drug is new and unproved, it is only offered to people who have no other reasonable options; that is, nothing to lose.

Phase II.

A drug that has been phase I tested and shows clear signs of effectiveness without undue risk is admitted to this phase. It is offered to a broader group of patients to better establish its value as a new treatment.

Phase III.

Here, a new treatment is compared to existing treatments, or to no treatment at all. In phase III, some patients receive the new treatment, while others receive a more conventional treatment or a placebo (which is not a treatment, but appears to be one). If a treatment is clearly safer and more effective than the alternatives, the FDA will sometimes allow this phase of testing to be ommitted, putting the treatment on the fast track to full approval.

By nature, clinical trials are at the cutting edge of medicine. Tomorrow's standard treatments are found in today's trials. While not all clinical trials lead to improvement in one's illness, many do.

For more information on clinical trials and other aspects of cancer treatment, visit any one of the following sites:

• Steve Dunn: CancerGuide
• National Cancer Institute
• International Cancer Information Center
• Oncolink