Handbook of Adaptive Designs in Pharmaceutical and Clinical Development (eBook, PDF)

Redaktion: Pong, Annpey; Chow, Shein-Chung

• Format: PDF

Produktbeschreibung

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 496
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781439810170
• Artikelnr.: 57534099

Autorenporträt

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also the associate editor of the Journal of Biopharmaceutical Statistics. She earned her Ph.D. in statistics from Temple University. Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School and the editor of the Journal of Biopharmaceutical Statistics. He earned his Ph.D. in statistics from the University of Wisconsin-Madison.

Inhaltsangabe

Overview of Adaptive Design Methods in Clinical Trials. Fundamental Theory
of Adaptive Designs with Unplanned Design Change in Clinical Trials with
Blinded Data. Bayesian Approach for Adaptive Design. The Impact of Protocol
Amendments in Adaptive Trial Designs. From Group Sequential to Adaptive
Designs. Determining Sample Size for Classical Designs. Sample Size
Reestimation Design with Applications in Clinical Trials. Adaptive Interim
Analyses in Clinical Trials. Classical Dose-Finding Trial. Improving
Dose-Finding: A Philosophic View. Adaptive Dose-Ranging Studies. Seamless
Phase I/II Designs. Phase II/III Seamless Designs. Sample Size
Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs.
Optimal Response-Adaptive Randomization for Clinical Trials.
Hypothesis-Adaptive Design. Treatment Adaptive Allocations in Randomized
Clinical Trials: An Overview. Integration of Predictive Biomarker
Diagnostics into Clinical Trials for New Drug Development. Clinical
Strategy for Study Endpoint Selection. Adaptive Infrastructure. Independent
Data Monitoring Committees. Targeted Clinical Trials. Functional
Genome-Wide Association Studies of Longitudinal Traits. Adaptive Trial
Simulation. Efficiency of Adaptive Designs. Cases Studies in Adaptive
Design. Good Practices for Adaptive Clinical Trials. Index.