Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - July 18, 1989
Brad Stone - (301) 443-3285
"The AIDS Clinical Trial Information Service is on-line and ready to provide the public with basic information concerning clinical trials," Secretary Sullivan said. "The data bank will provide the answers to important basic questions and tell individuals where to get further details."
The listings were completed by a new data base developed by the Food and Drug Administration on clinical trials sponsored by private companies and organizations. This information complements that on federally sponsored trials furnished by the National Institute of Allergy and Infectious Diseases. Both are accessible via a Public Health Service toll-free hotline at 1-800 TRIALS-A. The Centers for Disease Control will administer the operation of this hotline as part of its AIDS Information Clearinghouse.
The Public Health Service AIDS Clinical Trials Information Service was designed to provide greater access to information about the trials underway to test the efficacy of proposed treatments for AIDS and related conditions.
The Public Health Service AIDS Clinical Information Service was mandated by the Health Omnibus Programs Extension Act passed by Congress in November 1988. The legislation also exempted basic information about clinical efficacy trials for AIDS-related treatments from federal laws which had barred FDA from disclosing any information on clinical trials without the sponsor's permission.
FDA Commissioner Frank E. Young, M.D., Ph.D., said, "It is important that people obtain early information on efficacy trials, which a change in the law now permits us to provide. The information will enable people with AIDS to identify clinical trials more quickly and efficiently, and participate in them more widely."
The FDA data base, which began operation today, contains information on every experimental AIDS and AIDS-related treatment undergoing clinical testing for efficacy in FDA-sanctioned trials. The information will include the name of the drug being tested, the indication for which the treatment is being tested, eligibility criteria for patient enrollment and the location of the clinical trial sites. In addition, FDA has requested each clinical trial sponsor to allow the release of information beyond that required by the law, including information about other experimental drugs that are in earlier, pre-efficacy stages of testing.
FDA's recently established AIDS coordination staff developed this data base, working with other parts of the agency and with the pharmaceutical industry.
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SOURCE: Food and Drug Administration (FDA).
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