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Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. It examines the drug development process from the perspectives of drug companies and regulatory agencies. Drawing on his extensive work as a statistician in the pharmaceutical industry, the author focuses on the efficient development of drugs and the quantification of evidence in drug development. He provides a rationale for underpowered phase 2 trials based on the notion of efficiency, which leads to the identification of an admissible family of phase 2 designs. He also develops a framework for evaluating the strength of evidence generated by clinical trials. This approach is based on the ratio of power to type 1 error and transcends typical Bayesian and frequentist statistical analyses.

Theory of Drug Development

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THEORY OF DRUG DEVELOPMENT

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Front Cover.
Half Title Page.
Other Frontmatter.
Other Frontmatter.
Title Page.
Copyright Page.
Contents.
Preface.
Author.
Introduction.
A Theory of Evaluating Drugs.
1: Clinical Drug Development Phases 1 Through 3.
2: Choosing Drugs to Develop.
3: Phase 2/3 Strategy.
4: Maximize the Minimum Efficiency.
5: Single-Arm Phase 2 Trial.
6: Phase 2 Trials Based on Surrogate Endpoints.
7: Dose Selection and Subgroups: Phase 2 as a Pilot Trial.
8: Multistage Screening.
A Theory of Evidence in Drug Development.
9: Preference for Simple Tests of Hypotheses over Model-Based Tests.
10: Quantifying the Strength of Evidence from a Study.
11: Quantifying the Strength of Evidence: A Few Additional Comments on Interim Analyses.
12: Confirmatory Trials.
Additional Topics.
13: Maximize Efficiency Subject to a Constraint on the Ratio of True to False Positives.
14: Power of the Log Rank Test to Detect Improvement in Mean Survival Time and the Impact of Censoring.
15: Adaptive Phase 2/3 Designs.
16: Size of the Phase 3 Trial.
17: Extending the Model of Clinical Drug Development.
Appendix A: Maximize Relative Efficiency.
Appendix B: An Essentially Complete Class of Phase 2 Screening Trials.
Appendix C: Monotonicity of Power/Type 1 Error.
Appendix D: The Log Rank Test Maximizes the Power under Proportional Hazards.
Appendix E: Approximation of the Log Rank Test.

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Theory of Drug Development