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Experimental Treatments? Unapproved But Not Always Unavailable

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Finding Information about Investigational New Drugs continued...

CancerNet (http://cancernet.nci.nih.gov) is run by NIH's National Cancer Institute (NCI). It provides information on clinical trials. Information is also available through NCI's Cancer Information Service at 1-800-4-CANCER.

ACTIS (www.actis.org), the AIDS Clinical Trials Information Service, provides a wide range of information on current AIDS research, including drug trials, vaccine trials, and other educational material. Sponsored by the U.S. Public Health Service, including FDA, NIAID, Centers for Disease Control and Prevention, and the National Library of Medicine, ACTIS also can be reached at 1-800-TRIALS-A.

Information regarding clinical trials for rare disease can be found at http://rarediseases.info.nih.gov/ord/research-ct.html, a database compiled by NIH's Office of Rare Diseases.

CenterWatch Clinical Trials Listing Service (www.centerwatch.com) is published on the Internet by CenterWatch Inc., a multimedia publishing company in Boston, MA. It provides information on more than 5,000 active clinical trials as well as other information.

When a clinical trial is not an option, FDA facilitates access to an investigational new drug or an investigational medical device through other programs. For information on programs for, or access to, an unapproved investigational new drug, call FDA's Office of Special Health Initiatives at 301-827-4460.

Is the Risk Worth It?

No matter how promising a clinical trial or investigational new drug seems, there is no way to know about all the risks before the study begins. While the hope is that the study will produce a cure, it's important to recognize that risks can prove significant. For example, in 1992, tests for a promising hepatitis B drug severely damaged the liver in 10 patients. Some died and others required liver transplants.

Because of these inherent uncertainties the health-care professionals conducting the study must ensure that the patient understands the risks as well as the benefits beforehand and is willing to proceed.

Here are some questions patients might want to ask to make sure they understand the consequences of entering a study or using an investigational new drug:

1. What are the potential benefits from the treatment being studied? What have the animal or other human studies shown about the effectiveness of the drug?

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