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Interface between Regulation and Statistics in Drug Development

Fundamental Principles of Clinical Trials INTRODUCTION GENERAL STATISTICAL CONSIDERATIONS EVOLVING ROLES OF THE STATISTICIAN IN DRUG DEVELOPMENT POTENTIAL STATISTICAL ISSUES IN REGULATORY REVIEW CONCLUDING REMARKS BIBLIOGRAPHY Selected Statistical Topics of Regulatory Importance INTRODUCTION MULTIPLICITY Multiple Endpoints Multiple Testing Over the Course of the Study MISSING VALUES AND ESTIMANDS General Considerations Missingness Mechanisms Approaches for Missing Data Sensitivity Analyses Estimands and Other Recent Regulatory Developments Concluding Remarks NON-INFERIORITY STUDY INNOVATIVE TRIAL DESIGNS Adaptive Designs Adaptive Randomization Sample Size Reestimation Sequential Designs Adaptive Designs for Dose and Treatment Selection Adaptive Enrichment Designs Master Protocols BAYESIAN ANALYSIS IN A REGULATORY FRAMEWORK Introduction Potential Areas of Application Regulatory Considerations Challenges with Bayesian Statistics Concluding Remarks SURROGATE ENDPOINTS AND BIOMARKERS Introduction Statistical Considerations Regulatory Considerations Concluding Remarks SUBGROUP ANALYSES BENEFIT-RISK ASSESSMENT Introduction Methodological Considerations in Benefit-Risk Analysis Regulatory Perspectives Benefit-Risk in Health-Technology Assessment Concluding Remarks BIBLIOGRAPHY Statistical Engagement in Regulatory Interactions INTRODUCTION INTERNAL BEHAVIORS DATA MONITORING COMMITTEE REGULATORY MEETINGS AND ADVISORY COMMITTEE MEETINGS STATISTICAL ROLE IN PROMOTIONAL MATERIAL AND MEDICAL COMMUNICATION CONCLUDING REMARKS BIBLIOGRAPHY Emerging Topics THE USE OF RWE TO SUPPORT LICENSING AND LABEL ENHANCEMENT Introduction Methodological and Operational Considerations Current Regulatory Landscape Concluding Remarks PATIENT-REPORTED OUTCOMES IN REGULATORY SETTINGS Introduction Development and Validation of PRO Instruments Statistical Considerations Regulatory Considerations Concluding Remarks ARTIFICIAL INTELLIGENCE AND MODERN ANALYTICS IN REGULATORY SETTINGS Introduction Al in Drug Development Regulatory Experience with Machine Learning and Artificial Intelligence Concluding Remarks BIBLIOGRAPHY

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