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Controversial Statistical Issues in Clinical Trials Chapman Hall CRC Biostatistics Series 1st Edition by Shein Chung Chow ISBN 978-0367576936 0367576937

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Controversial Statistical Issues in Clinical Trials Chapman Hall CRC Biostatistics Series 1st Edition Shein-Chung Chow Digital Instant Download

Author(s): Shein-Chung Chow
ISBN(s): 9781439849620, 1439849625
Edition: 1
File Details: PDF, 6.68 MB
Year: 2011
Language: english
SKU: EB-2501074 Category: Tag:

Controversial Statistical Issues in Clinical Trials Chapman Hall CRC Biostatistics Series 1st Edition by Shein-Chung Chow  – Ebook PDF Instant Download/Delivery:  978-0367576936, 0367576937
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Product details: 

ISBN 10:   0367576937

ISBN 13: 978-0367576936

Author: Shein-Chung Chow

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems.

The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems.

Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.

Table of contents: 

  1. Introduction

  2. Good Statistical Practices

  3. Bench-to-Bedside Translational Research

  4. Bioavailability and Bioequivalence

  5. Hypotheses for Clinical Evaluation and Significant Digits

  6. Instability of Sample Size Calculation

  7. Integrity of Randomization and Blinding

  8. Clinical Strategy for Endpoint Selection

  9. Protocol Amendments

  10. Seamless Adaptive Trial Designs

  11. Multiplicity in Clinical Trials

  12. Independence of Data Monitoring Committee

  13. Two-Way ANOVA versus One-Way ANOVA with Repeated Measures

  14. Validation of Quality of Life (QOL) Instruments

  15. Missing Data Imputation

  16. Center Grouping

  17. Non-Inferiority Margin

  18. QT Studies with Recording Replicates

  19. Multiregional Clinical Trials

  20. Dose Escalation Trials

  21. Enrichment Process in Target Clinical Trials

  22. Clinical Trial Simulation

  23. Traditional Chinese Medicine

  24. The Assessment of Follow-On Biologic Products

  25. Generalizability and Reproducibility Probability

  26. Good Review Practices

  27. Probability of Success

  28. References

  29. Index

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Tags: Shein Chung Chow, Controversial Statistical, Clinical Trials