Experimental Treatments? Unapproved But Not Always Unavailable
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
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
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?