Thursday, September 21

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Pdf Free

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development: This book is written by Annpey Pong and Shein-Chung Chow which you can download freely in Pdf Format. In response to the US FDA’s Critical Path initiative, innovative adaptive designs are increasingly used in clinical trials due to their flexibility and efficiency, especially during early development. The Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying assay procedures based on data accumulated from ongoing clinical trials. The book also provides a well-balanced summary of the current regulatory outlook.

The first few chapters focus on the fundamental theory behind the adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population change due to protocol modifications. The book then introduces a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III continuous adaptive trial designs, staged continuous adaptive trial design multiple, adaptive randomization trials, and adaptive hypothesis design. and design adaptable to treatment. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data review boards in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, adaptive design applications using genomics or genetic information, adaptive test simulation, and adaptive design efficiency. The final chapters discuss case studies as well as standard operating procedures for good adaptation practices.


Book Name Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
Author of Book Annpey Pong, and Shein-Chung Chow
Language English
Format PDF
Category Pharmaceuticals Books


Overview of Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Pdf Free

According to Annpey Pong, and Shein-Chung Chow, in a traditional clinical trial, the design is set in advance, the study is carried out, and the data is analyzed after completion. In contrast, adaptive designs plan for potential modifications in advance based on data that accumulates over the course of the trial as part of the trial protocol. We consider designs that allow for trial modifications, such as sample size, number of treatments, or proportion of assignment to different arms. We do not consider options such as early stopping due to non-compliance with operational criteria or excessive security events, although there are also adaptive designs for some of these. Adaptive design methodology has been around for more than 25 years, and some methods, such as group sequential designs, are even older.
It is crucial that the adaptive nature of a design does not undermine the integrity and validity of the trial. By completeness of a trial, we mean that the data have not been used in such a way as to substantially alter the result, while the validity of the results requires that the study adequately answer the original research questions. Adaptive designs require procedures to ensure that data is properly collected, analyzed, and stored at each stage of the trial, with the specialized statistical methodology for inference. The involved logistical and statistical nature of adaptive designs should also be reflected in your report. 

Topics of this Edition

  • 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.
  • The efficiency of Adaptive Designs.
  • Cases Studies in Adaptive Design.
  • Good Practices for Adaptive Clinical Trials.

About the Author

Annpey Pong is a manager in the Department of Biostatistics and Research Decision Sciences at Merck Research Laboratories. Dr. Pong is also associate editor of the Journal of Biopharmaceutical Statistics. He obtained his 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 School of Medicine and Editor of the Journal of Biopharmaceutical Statistics. He obtained his Ph.D. in statistics from the University of Wisconsin–Madison.




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