Clinical trial methodology /
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| Author / Creator: | Peace, Karl E., 1941- |
|---|---|
| Imprint: | Boca Raton : Chapman and Hall/CRC Press, c2011. |
| Description: | 1 online resource. |
| Language: | English |
| Series: | Chapman & Hall/CRC biostatistics series ; 35 Chapman & Hall/CRC biostatistics series ; 35. |
| Subject: | |
| Format: | E-Resource Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/8134073 |
Table of Contents:
- 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