Handbook of Adaptive Designs in Pharmaceutical and Clinical Development: 1st Edition (e-Book) book cover

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

1st Edition

Edited by Annpey Pong, Shein-Chung Chow

CRC Press

496 pages

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Hardback: 9781439810163
pub: 2010-10-25
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Description

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

Table of Contents

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.

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy