Clinical Trial Methodology
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Clinical Trial Methodology

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Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors' courses on the subject as well as the first author's more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors' own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer's disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.show more

Product details

  • Hardback | 420 pages
  • 160.02 x 233.68 x 25.4mm | 703.06g
  • Taylor & Francis Inc
  • Chapman & Hall/CRC
  • Boca Raton, FL, United States
  • English
  • 34 black & white illustrations, 83 black & white tables
  • 1584889179
  • 9781584889175
  • 1,551,666

Review quote

This comprehensive text introduces the key areas of clinical trial methodology from the perspective of the biostatistician in the pharmaceutical industry. ... Throughout, the text benefits from a highly structured and logical flow ... the arguments made in the book are grounded in many years of practical experience in drug development and at the very least will act as a prompt for in-depth discussion or critical review of one's own perceptions. ... Clinical Trial Methodology will be of substantial value to early career pharmaceutical industry statisticians. -Christopher J. Weir, Pharmaceutical Statistics, 2012 ... informative discussions of mechanisms such as IND and NDA ... are unique strengths of this book, distinguishing it from the many other clinical trial texts available. ... Case studies ... are presented carefully ... The authors' writing style is disciplined, careful, and informative. ... this is a helpful and informative book, a nice reference to have for most biostatisticians working on clinical trials. -Mithat Gonen, Journal of Biopharmaceutical Statistics, 21, 2011 The book is an excellent overview predicated on the first author's seasoned experiences in designing, analyzing, and communicating the results of clinical trials across a broad number of medical disciplines. ... A nice introductory feature is the history of drug law and regulation, which helps to frame the subsequent statistical discussion nicely. ... The real-world examples that dominate the last few chapters are fantastic. ... There is nothing like a series of examples from an experienced clinical trialist to whet the appetite of those involved in the noble enterprise of medical (and more specifically pharmaceutical) research with the goal of improving the public's health. This book does an admirable job in giving the regulatory and statistical foundations for clinical trials, coupled with real-world examples of how statistical methodology has guided the development of important medicines. ... -Gregory Enasshow more

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.show more

About Karl E. Peace

Karl E. Peace is the Georgia Cancer Coalition Distinguished Cancer Scholar, founding director of the Center for Biostatistics, and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University. Din Chen is the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics and professor of biostatistics in the Jiann-Ping Hsu College of Public Health at Georgia Southern University.show more