Review of the Fialuridine (FIAU) Clinical Trials

Frederick J. Manning and Morton Swartz, Editors; Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials, Institute of Medicine

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• 1 Front Matter; 2 Executive Summary; 3 Introduction; 4 Clinical Trials; 5 Hepatitis B and Other Viral Diseases; 6 Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center; 7 Oclassen Clinical Trial R89-001-01; 8 Oclassen Clinical Trial R90-001-01 (NIH Protocol 91-AI-0031); 9 Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213); 10 Eli Lilly Trial H3X-MC-PPPA; 11 Eli Lilly Trial H3X-MC-PPPG; 12 Eli Lilly Trial H3X-MC-PPPC (NIH Protocol 93-DK-0031); 13 Summary of Patient Interviews; 14 Overall Assessment of the Trials; 15 Recent Studies of FIAU Toxicity; 16 Review of the FDA Task Force Report 'Fialuridine: Hepatic and Pancreatic Toxicity'; 17 Review of 'Report to the Advisory Committee to the Director, National Institutes of Health'; 18 FDA-Proposed Changes to the Code of Federal Regulations; 19 Ancillary Issues Raised During the Period Following The H3X-MC-PPPC Trial; 20 Conclusions and Recommendations; 21 Appendix A: Chronology of FIAU/FIAC Clinical Trials; 22 Appendix B: Bibliography and References; 23 Appendix C: Agendas from the Three Committee Meetings; 24 Appendix D: Informed Consent Documents; 25 Appendix E: Example of Oclassen Fax Data Summaries; 26 Appendix F: FIAC and FIAU Preclinical Toxicity Studies; 27 Appendix G: Patient Summaries, Lilly Trial H3X-MC-PPPA; 28 Appendix H: Statistical Analysis of Mortality in the FIAU/FIAC Clinical Trials; 29 Glossary