Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Introduction
Introduction
Pages 16-19
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From page 16... ...
At this point all patients still taking FIAU were told to stop taking it, but this did not prevent serious additional toxicity. In retrospect, the committee can identify the distinctive characteristics of this severe toxicity: hepatic (liver)
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From page 17... ...
In it TOM was tasked to assemble a committee of experts in a variety of fields (clinical research, pharmacology, toxicology, and medical ethics as well as hepatology) to perform a thorough analysis of all the FTAU clinical trials, as well as those of fiacitabine (FlAC; a related compound that is rapidly converted to FlAU in the human body)
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From page 18... ...
The subsequent section of the report provides the committee's analysis of the whole series of trials with respect to such issues as informed consent, oversight, reporting of adverse events, and response to the emergency. Next the report reviews and comments on the patient interviews and the previous professional reviews: the FDA Task Force Report, the NTH Review, the FDA warning letters, and the changes to the Code of Federal Regulations recently proposed by FDA.
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From page 19... ...
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