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Review of the Fialuridine (FIAU) Clinical Trials (1995)
Institute of Medicine (IOM)

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. "Eli Lilly Trial H3X-MC-PPPA." Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press, 1995.

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Review of the Fialuridine (FIAU) Clinical Trials

the informed consent form and finds it to be of generally high quality, but noted that it did not include specific reference to the clinical manifestations of peripheral neuropathy. The patient who developed peripheral neuropathy recalled that during the last or penultimate scheduled visit he happened to mention to the study nurse numbness in his toes, which he attributed to wearing ''flip-flops.'' She insisted on setting up an appointment with a neurologist to evaluate this symptom. Neither subject would consider volunteering for further studies of new hepatitis drugs, but one indicated that it was because he could not take time off from work.

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Front Matter (R1-R10)
Executive Summary (1-15)
Introduction (16-19)
Clinical Trials (20-33)
Hepatitis B and Other Viral Diseases (34-41)
Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center (42-50)
Oclassen Clinical Trial R89-001-01 (51-54)
Oclassen Clinical Trial R90-001-01 (NIH Protocol 91-AI-0031) (55-60)
Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213) (61-65)
Eli Lilly Trial H3X-MC-PPPA (66-69)
Eli Lilly Trial H3X-MC-PPPG (70-72)
Eli Lilly Trial H3X-MC-PPPC (NIH Protocol 93-DK-0031) (73-89)
Summary of Patient Interviews (90-92)
Overall Assessment of the Trials (93-97)
Recent Studies of FIAU Toxicity (98-103)
Review of the FDA Task Force Report 'Fialuridine: Hepatic and Pancreatic Toxicity' (104-120)
Review of 'Report to the Advisory Committee to the Director, National Institutes of Health' (121-132)
FDA-Proposed Changes to the Code of Federal Regulations (133-142)
Ancillary Issues Raised During the Period Following The H3X-MC-PPPC Trial (143-149)
Conclusions and Recommendations (150-154)
Appendix A: Chronology of FIAU/FIAC Clinical Trials (155-164)
Appendix B: Bibliography and References (165-177)
Appendix C: Agendas from the Three Committee Meetings (178-183)
Appendix D: Informed Consent Documents (184-243)
Appendix E: Example of Oclassen Fax Data Summaries (244-245)
Appendix F: FIAC and FIAU Preclinical Toxicity Studies (246-250)
Appendix G: Patient Summaries, Lilly Trial H3X-MC-PPPA (251-255)
Appendix H: Statistical Analysis of Mortality in the FIAU/FIAC Clinical Trials (256-265)
Glossary (266-269)