Tabla de Contenidos: “…Review of the Fialuridine (FIAU) Clinical Trials -- Copyright -- Preface -- Contents -- Executive Summary -- INTRODUCTION -- CLINICAL TRIALS -- HEPATITIS B AND OTHER VIRAL DISEASES -- EARLY CLINICAL TRIALS OF FIAC AT MEMORIAL SLOAN-KETTERING CANCER CENTER -- OCLASSEN CLINICAL TRIAL R89-001-01 -- OCLASSEN CLINICAL TRIAL R90-001-01 -- OCLASSEN CLINICAL TRIAL R-91-010 -- ELI LILLY CLINICAL TRIAL H3X-MC-PPPA -- ELI LILLY TRIAL H3X-LC-PPPG -- ELI LILLY TRIAL H3X-MC-PPPC (NIH PROTOCOL #93-DK-0031) -- PATIENT INTERVIEWS -- OVERALL ASSESSMENT OF THE TRIALS -- REVIEW OF THE FDA TASK FORCE REPORT -- REVIEW OF THE NIH REPORT -- FDA-PROPOSED CHANGES TO THE CODE OF FEDERAL REGULATIONS -- ANCILLARY ISSUES -- CONCLUSIONS -- RECOMMENDATIONS -- Generic Issues -- Trial Design -- Adverse Event Reporting -- Compliance Audits -- Further Research Into FIAU Toxicity -- 1 Introduction -- GENESIS OF THIS STUDY -- CHARGE TO THE COMMITTEE -- METHODS AND PROCEDURE -- PLAN OF THE REPORT -- 2 Clinical Trials -- IMPORTANCE OF CLINICAL TRIALS -- THE RISK-BENEFIT NATURE OF TRIALS -- THE DRUG DEVELOPMENT PROCESS -- SAFETY REPORTS -- ETHICAL CONSIDERATIONS -- Procedural Requirements -- Substantive Norms -- A Favorable Balance of Harms and Benefits -- Equitable Selection of Subjects -- Compensation for Research-Related Injury -- Informed Consent -- SUMMARY -- 3 Hepatitis B and Other Viral Diseases -- NATURE OF CHRONIC VIRAL DISEASES -- NATURAL HISTORY OF CHRONIC HBV INFECTION -- NEED FOR ORALLY ACTIVE AGENTS -- THE FLARE PHENOMENON -- TOXIC EFFECTS OF OTHER NUCLEOSIDE ANALOGS -- SUMMARY -- 4 Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center -- PHASE I EVALUATION OF FIAC IN IMMUNOSUPPRESSED PATIENTS WITH HERPESVIRUS INFECTION -- Comment -- PHASE I STUDY OF AIDS PATIENTS WITH PRESUMPTIVE OR PROVEN HERPESGROUP VIRUS INFECTION -- Comment…”

“…It considers the classroom as a space of "trial and error" and, therefore, of necessary innovation. …”