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Conclusions and Recommendations
Pages 150-154

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From page 150...
... The recommendations of this IOM committee, as the earlier recommendations of the NIH subcommittee and the FDA, have the goal of reducing to a minimum the possible occurrence of such a calamity in any future clinical drug trials, but their implementation cannot render the process absolutely risk free. At the same time we believe that the recommendations are not so stringent or onerous as to restrict the benefits to the ill that can accrue from successful new drug development.
From page 151...
... Skilled clinical investigators in the field of drug development are a valuable national resource who can reduce the burden of pain, illness, and premature death. The committee has found nothing in its review to suggest that the tragedy was preventable given the heretofore unobserved and unanticipated late complication of the treatment.
From page 152...
... found that in Phase ~ drug testing in prisoners a "clinically significant medical event" occurred once every 26.3 years of individual subject exposure. In 805 protocols involving 29,162 prisoner subjects over 614,534 days, there were 58 adverse drug reactions, of which none produced death or permanent disability.
From page 153...
... Such control groups may be needed for comparisons when suitably matched concurrent control groups are not feasible. The extensive data submitted to FDA through the IND process are a potentially valuable resource for custom matching patients in new drug trials with controls from previous trials, matching not only for entry criteria but also for disease extent and severity, concomitant medications and other confounding variables.
From page 154...
... Some sort of appeal process, independent of the FDA Office of Compliance, and including scientific peers expert in the area, should also be available in the event of intractable disagreement, and when retrospective evaluation by the Office of Compliance is at odds with the prior evaluation of the responsible review division, that fact should at least be acknowledged in the letter. Further Research into FlAU Toxicity 14.


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