Clinical Trial Methodology

ISBN-10: 1584889179

ISBN-13: 9781584889175

Edition: 2010

Authors: Karl E. Peace
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Description: Taking a case study approach, this book provides a thorough presentation of clinical trial methodology based on the author’s own experiences in many areas of clinical drug development. It begins with a review of important legislation pertinent to the clinical development of drugs. The book then presents the processes of drug research and development within the context of a typical pharmaceutical company. The author also discusses general biostatistical principles of clinical trials, including protocol development and statistical analysis plan development. In addition, he includes real-world case studies of a range of clinical trials.

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Book details

List price: $109.95
Copyright year: 2010
Publisher: CRC Press LLC
Publication date: 7/20/2010
Binding: Hardcover
Pages: 420
Size: 6.25" wide x 9.50" long x 1.00" tall
Weight: 1.584
Language: English

Overview of Clinical Trial Methodology
Clinical Trials
Clinical Trial Methodology
Summary of Clinical Trial Methodology
Overview of the Drug Development Process and Regulation of Clinical Trials
Introduction
The Drug Development Process
History of Drug Regulation
Principles of Adequate and Controlled Investigations
Content and Format of the IND
Content and Format of the NDA
Organizational Structure of the FDA
The FDA Review Process
Labeling and the Package Insert
Pharmaceutical Company Organization and Role of the Biostatistician
Ethical Considerations in the Design and Conduct of Clinical Trials
Introduction
History and Evolution of Ethical Considerations in Clinical Trials: Key Milestones
Independent Review Boards
Clinical Trial Ethics: Who Should Practice?
Informed Consent, Sample Size, and Power
Common Ethical Principles of Various Codes and Regulations
Sample Size Considerations in Clinical Trials Pre-Market Approval
Introduction
Phases of Clinical Trials and Objectives
The Clinical Development Plan: Pre-Market Approval
Sample Size Requirements
Examples
Philosophical Issues
Sequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials
Introduction
Sequential Procedures
Group Sequential Procedures
Stochastic Curtailment
Adaptively Designed Clinical Trials
Biostatistical Aspects of the Protocol
The Background or Rationale
Objective
Plan of Study
Statistical Analysis Section
Administration
Protocol References Section
The Statistical Analysis Plan
Introduction
Protocol Objective
Efficacy Data Collected and Protocol Schema
Primary and Secondary Efficacy Endpoints
Objectives, Translated as Statistical Hypotheses
Protocol Design Features
Statistical Analyses
Pooling of Data from Multicenter Clinical Trials
Introduction
Multicenter Clinical Trial Experimental Setting
Pre-Study Planning
Multicenter Clinical Trial Conduct
Biostatistical Analysis
Validity of Statistical Inference
Introduction
Planning the Investigation
Conducting the Investigation
Statistical Analyses, Interpretation, and Inference
Reporting Results of Investigations
Bioequivalence Clinical Trials
Introduction
Absorption, Distribution, Metabolism, and Excretion (ADME)
Bioavailability
Factors That Affect Bioavailability
Blood Level Clinical Trials
Bioequivalence
Design of Bioequivalence Trials
Analysis of Bioequivalence Trials
Analysis of Ratios
Pharmacokinetic Models
Support of Bioequivalence Trials in the Pharmaceutical Industry
Examples
Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina
Introduction
Overview of Response Surface Methodology
Full Quadratic Response Surface Model
Phase II Clinical Trial Program in Stress Test-Induced Angina
Confirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial
Introduction
Background
Objective
Designing and Planning the Investigation
Conducting the Investigation
Statistical Analyses
Other Considerations
Innovative Aspects of the Clinical Trial Program
Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration
Introduction
Rationale
The Protocols
Monitoring and Data Management
FDA Meeting
Clinical Trials in the Treatment of Alzheimer's Disease Based upon Enrichment Designs
Introduction
Enrichment Design Clinical Trials
Objective
Primary Efficacy Endpoints
Sample Size Determination
Statistical Methods
Results
A Clinical Trial to Establish Reduction of CHD Risk
Introduction
Objective
Designing and Planning the Investigation
Conducting the Investigation
Data Management
Statistical Analyses
Results
Summary
Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder
Introduction
Design of Pivotal Proof-of-Efficacy Trials
Traditional Statistical Analysis Methods
Overview of Efficacy Results of the Two Trials
Alternative Design and Analysis Strategies
Combination Clinical Trials
Introduction
Two-by-Two Factorial Design
Effectiveness of the Combination
Contribution of Components to the Effectiveness of the Combination
Factorial Designs in Other Clinical Development Areas
Example 1: Actifed in the Treatment of SAR Following DESI Review
Example 2: Crossover Trial of Actifed in the Treatment of SAR
Example 3: Parallel Trial of Actifed in the Treatment of the Common Cold
Monitoring Clinical Trials for Adverse Events
Introduction
Designing for Safety: Antibiotic Rash Example
Designing for Safety: Hypokalemia Example
Designing for Safety: Hypertensive Rebound Example
Premarket Approval Trials: Designed for Efficacy
Premarket Approval Trials: Quality of Adverse Event Information
Monitoring for Safety
Statistical Methodology: Individual Trial
Example
Statistical Methodology: Across Trials
Index
References appear at the end of each chapter
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