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Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
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Overall Assessment of the Trials
Pages 93-97

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From page 93...
... The TOM committee found these documents to be of generally very high quality. In the opinion of the IOM committee, there were no clear departures from the requirements of relevant federal regulations.
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From page 94...
... On review of this matter, the IOM committee finds that the monitoring of such data was not merely adequate; when considered in the light of prevailing practices in the field, the monitoring activities of these research groups and the sponsors were exemplary. Interpretation of such data, particularly data indicating either damage to the liver or diminishing liver function, was not recognized promptly as indicating drug toxicity for at least three reasons.
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From page 95...
... In consideration of the possibility that at least some of the subjects might have been relatively impoverished in that they would be unable to secure medical services of high quality without participation in these studies, there was a need to be especially careful to avoid offering "undue" material inducements in the form of cash payments. The IOM committee found no evidence of undue inducements.
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From page 96...
... Compensation for Research-Related Injury The consent documents for each of the protocols reviewed by the lOM committee were in compliance with the regulatory requirement to provide "an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained." There is no question that all possible steps were taken by the N] :H investigators and Eli Lilly to insure that the patients injured in trial PPPC received whatever medical care was necessary.
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From page 97...
... OVERALL ASSESSMENT OF THE TRIALS 97 SUMMARY The overall impression of the TOM committee is that these trials were ethically sound clinical research projects designed and carried out by highly competent investigators who frequently went beyond the requirements dictated by regulations or imposed by TRBs to respond to the desires and needs of their patient-subjects. Indeed, with rare exceptions, their relationships with the patient-subjects appeared to have elements of the depth and sensitivity to which good primary care physicians aspire in their relationships with their patients.
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Key Terms

  • liver function
  • prospective subjects
  • chronic hepatitis
  • consent documents
  • informed consent

  • ethical justification
  • noted earlier
  • pppc trial
  • research subjects
  • drug toxicity

  • undue inducements
  • mention peripheral
  • received whatever
  • administered oral
  • pppc received

  • consent form
  • special populations
  • developing neuropathy
  • spoke candidly
  • medical ethics

  • satisfactory resolution
  • develop knowledge
  • medical treatments
  • indicate damage
  • regulatory requirement

  • recognized promptly
  • informing prospective
  • injury occurs
  • research nurses
  • oral medication


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