Eric B. Holmgren

Theory of Drug Development (eBook, PDF)

• Format: PDF

Produktbeschreibung

This book focuses on the efficient development of drugs and the quantification of evidence in drug development. It presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. Examining the drug development process from the perspectives of both drug companies and regulatory agencies, the author provides a rationale for underpowered phase 2 trials based on the notion of efficiency and develops a framework for evaluating the strength of evidence generated by clinical trials.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 261
• Erscheinungstermin: 24. Oktober 2013
• Englisch
• ISBN-13: 9781466507470
• Artikelnr.: 40345257

Autorenporträt

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.

Inhaltsangabe

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.

Rezensionen

"'In each chapter, author provides appropriate statistical formulas that readers can actually utilize. Since this book handles many mathematical formulas, and contains many real good examples, this book would be very useful for statisticians who work at pharmaceutical companies and are deeply involved with drug development ... Overall, this book covers necessary and important aspects for drug development, and would be quite useful to clinical statisticians."'
-Byung-Ho Nam, PhD, Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Korea, in Biometrics

"The given book presents a theory of drug development that is based on maximizing the efficiency with which drugs that truly provide clinical benefits are identified. The author shows how to optimize the drug development process at its three main stages (Phases 1, 2, 3), and at some transitional sub-stages, so that the number of molecules that result in a positive final Phase 3 clinical trial per investment is maximized."
-Fatima T. Adylova in Zentralblatt MATH