Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Ancillary Issues Raised During the Period Following The H3X-MC-PPPC Trial
Ancillary Issues Raised During the Period Following The H3X-MC-PPPC Trial
Pages 143-149
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From page 143... ...
in all instances the committee's concern has been to reduce as far as possible the chance of such an unanticipated misfortune ever occurring again in the course of a clinical drug trial. This is done with the acknowledgment of the benefits that can accrue to society as a whole by the performance of clinical trials in the drug discovery process, and with the recognition that the measures recommended here cannot provide absolute assurance against the appearance of an unanticipated type of toxicity during the course of early clinical trials of some yet untested class of promising drugs in the future.
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From page 144... ...
On other occasions this is followed up with letters notifying investigators or sponsors of problems or violations noted in the audit. Letters conveying such information are broadly referred to as warning letters and in terms of action indicated are classified as no action indicated (NAT)
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From page 145... ...
It goes on to say: FDA's warning letters show that the drug companies and the investigators repeatedly and flagrantly violated FDA regulations, study protocols and good medical practice. In view of the death and suffering their negligence causecl innocent victims their behavior and actions are reprehensible, unconscionable and inexcusable.
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From page 146... ...
The committee believes that the NTH investigators' view was a legitimate one, and is supported by the minimal enzyme elevations which characterized the toxic syndrome of the PPPC victims. The committee recognizes nonetheless that there is room for reasonable persons to disagree with that position.
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From page 147... ...
As of the committee's last meeting on November 17, 1994, none of the original addressees had received any response from FDA to their rapidly crafted responses of the previous Spring. The review process carried out by the FDA and culminating in warning letters leaves much to be desired.
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From page 148... ...
The same should apply for investigators engaged in IND work. A reduction in the perceptual gap between investigators and FDA compliance personnel may be accomplished by a continuing dialogue between interested parties, perhaps in the form of an annual workshop jointly sponsored by FDA, the pharmaceutical industry, and members of the academic community.
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From page 149... ...
. This view is disturbing from the perspective of an investigator, if for no other reason than that it seems apparent that given variation in patient needs there is no trial, regardless of how meticulously performed, capable of passing muster if it is subjected to sufficient retrospective scrutiny.
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