Controversial statistical issues in clinical trials
"Preface In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate safety and efficacy of the test drug or treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study design are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessm…
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- Full title :Controversial statistical issues in clinical trials / Shein-Chung Chow.
Summary
"Preface In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate safety and efficacy of the test drug or treatment under investigation. To provide accurate and reliable assessment, well-controlled clinical trials under valid study design are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessment of the test treatment under investigation. Clinical trial process consists of protocol development, trial conduct, data collection, statistical analysis/interpretation, and reporting. In practice, controversial issues evitably occur regardless the compliance of good statistical practice (GSP) and good clinical practice (GCP). Controversial issues in clinical trials are referred to as debatable issues that are commonly encountered during the conduct of clinical trials. In practice, controversial issues could be raised from, but are not limited to, (1) compromises between theoretical and real/common practices, (2) miscommunication and/or misunderstanding in perception/interpretation among regulatory agencies, clinical scientists, and biostatisticians, and (3) disagreement, inconsistency, miscommunication/misunderstanding, and errors in clinical practice."--
Read More ↓Edition Statements
- Publication Date:©2011.
Publication Statements
- Publisher(s):CRC Press
- Place of Publication:Boca Raton
- Language:eng
- Publication Date:©2011.
The Physical Object
- Description:1 online resource (xix, 591 pages) : : illustrations
Edition Identifiers
- ISBN:9781439849620, 1439849625
- oclc:ocn750172564
- LC Classification:RM301.27
- Dewey Decimal:615.5072/4
Table of Contents
Introduction; Pharmaceutical Development; Controversial Issues; Aim and Structure of the Book Good Statistical Practices ; Statistical Principles; Good Statistical Practices in Europe; Implementation of GSP Bench-to-Bedside Translational Research ; Biomarker Development; One-Way/Two-Way Translational Process; Lost in Translation; Animal Model versus Human Model Bioavailability and Bioequivalence; Bioequivalence Assessment; Drug Interchangeability; Controversial Issues; Frequently Asked Questions Hypotheses for Clinical Evaluation and Significant Digits; Hypotheses for Clinical Evaluation; Statistical Methods for Testing Composite Hypotheses of NS; The Impact on Power and Sample Size Calculation; Significant Digits Instability of Sample Size Calculation ; Sample Size
Calculation; Instability and Bootstrap-Median Approach; Simulation Study; An Example Integrity of Randomization/Blinding ; The Effect of Mixed-Up Randomization; Blocking Size in Randomization; Test for Integrity of Blinding; Analysis under Breached Blindness; An Example Clinical Strategy for Endpoint Selection ; Clinical Strategy for Endpoint Selection; Translations among Clinical Endpoints; Comparison of Different Cl…
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