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FOREWORD
Introduction
Statutory and Regulatory Framework for Drug Approval
The Need for Early Randomization in the Development of New Drugs for AIDS
Design Considerations for AIDS Trials
Implications of an Alternative Approach to Dose–Response Trials
Design of Clinical Trials—Approaches to Clinical Trials Design
Design of Clinical Trials—Approaches To Clinical Trials Design
Rationale for Variations in Clinical Trial Design in Different HIV Disease Stages
AIDS in Intravenous Drug Users
Evaluation of the AIDS Dementia Complex in Clinical Trials
Practical Issues and Considerations in the Design of Clinical Trials for HIV-Infected Infants and Children
Considerations in the Selection of End Points for AIDS Clinical Trials
Laboratory Markers as Potential Surrogates for Clinical Outcomes in AIDS Trials
Design of Clinical Trials—End Points
Design of Clinical Trials—End Points
Designs of Clinical Trials
Evaluation of Active Control Trials in AIDS
Design of Clinical Trials—Active Control (Equivalence) Trials
Design of Clinical Trials—Active Control (Equivalence) Trials
Clinical Trials of Combination Therapies for HIV Infection Rationale For Development of Multidrug Therapy
Effectiveness of Multidrug Therapies in Tuberculosis
Strategies for the Combination Therapy of HIV Infection
Issues in the Testing of Drug Combinations
Clinical Trials of Combination Therapies for HIV Infection
Application of the Combination Index Method in the Design of a Clinical Antiretroviral Trial
Clinical Trials of Combination Therapies for HIV Infection
Intent-to-Treat Analysis
Data Monitoring and Sequential Analysis—An Academic Perspective
Analysis and Interpretation of Trial Results
Analysis and Interpretation of Trial Results
Incorporation of Trial Results into Clinical Practice