Theory of Drug Development 1st Edition by Eric Holmgren 9781466507470 1466507470

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Product details:

ISBN 10: 1466507470

ISBN 13: 9781466507470

Author: Eric B. Holmgren

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. By quantifying various ideas underlying drug development, the book shows how to systematically address problems, such as: Sizing a phase 2 trial and choosing the range of p-values that will trigger a follow-up phase 3 trial Deciding whether a drug should receive marketing approval based on its phase 2/3 development program and recent experience with other drugs in the same clinical area Determining the impact of adaptive designs on the quality of drugs that receive marketing approval Designing a phase 3 pivotal study that permits the data-driven adjustment of the treatment effect estimate Knowing when enough information has been gathered to show that a drug improves the survival time for the whole patient population 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.

Table of contents:

Section I: 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

Section II: 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

Section III: 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

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Tags: Eric Holmgren, Theory, Drug, Development