Theory of Drug Development
CRC Press (Verlag)
978-1-138-37468-3 (ISBN)
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.
Eric B. Holmgren is a consultant and statistical scientist. He previously worked at Genentech and Hoechst Roussel Pharmaceuticals. He received a Ph.D. in mathematical statistics from Stanford University.
A Theory of Evaluating Drugs: Clinical Drug Development Phases 1 through 3. Choosing Drugs to Develop. Phase 2/3 Strategy. Maximize the Minimum Efficiency. Single-Arm Phase 2 Trial. Phase 2 Trials Based on Surrogate Endpoints. Dose Selection and Subgroups: Phase 2 as a Pilot Trial. Multistage Screening. A Theory of Evidence in Drug Development: Preference for Simple Tests of Hypotheses over Model-Based Tests. Quantifying the Strength of Evidence from a Study. Quantifying the Strength of Evidence: A Few Additional Comments on Interim Analyses. Confirmatory Trials. Additional Topics: Maximize Efficiency Subject to a Constraint on True+/False+. Power of the Log Rank Test to Detect Improvement in Mean Survival Time and the Impact of Censoring. Adaptive Phase 2/3 Designs. Size of the Phase 3 Trial Extending the Model of Clinical Drug Development. Appendices.
| Erscheinungsdatum | 21.01.2019 |
|---|---|
| Reihe/Serie | Chapman & Hall/CRC Biostatistics Series |
| Zusatzinfo | 31 Tables, black and white; 50 Illustrations, black and white |
| Verlagsort | London |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 453 g |
| Themenwelt | Mathematik / Informatik ► Mathematik |
| Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie | |
| Naturwissenschaften ► Biologie | |
| Technik | |
| ISBN-10 | 1-138-37468-7 / 1138374687 |
| ISBN-13 | 978-1-138-37468-3 / 9781138374683 |
| Zustand | Neuware |
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