ABSTRACT

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 cov

chapter 1|16 pages

Introduction

chapter 2|14 pages

Good Statistical Practices

chapter 3|20 pages

Bench-to-Bedside Translational Research

chapter 4|18 pages

Bioavailability and Bioequivalence

chapter 6|16 pages

Instability of Sample Size Calculation

chapter 7|28 pages

Integrity of Randomization/Blinding

chapter 8|18 pages

Clinical Strategy for Endpoint Selection

chapter 9|24 pages

Protocol Amendments

chapter 10|26 pages

Seamless Adaptive Trial Designs

chapter 11|14 pages

Multiplicity in Clinical Trials

chapter 12|16 pages

Independence of Data Monitoring Committee

chapter 14|24 pages

Validation of QOL Instruments

chapter 15|16 pages

Missing Data Imputation

chapter 16|12 pages

Center Grouping

chapter 17|30 pages

Non-Inferiority Margin

chapter 18|20 pages

QT Studies with Recording Replicates

chapter 19|28 pages

Multiregional Clinical Trials

chapter 20|14 pages

Dose Escalation Trials

chapter 21|26 pages

Enrichment Process in Target Clinical Trials

chapter 22|22 pages

Clinical Trial Simulation

chapter 23|44 pages

Traditional Chinese Medicine

chapter 25|20 pages

Generalizability/Reproducibility Probability

chapter 26|16 pages

Good Review Practices

chapter 27|10 pages

Probability of Success