Kelly W.M. Kevin, Halabi Susan (eds.) Oncology Clinical Trials: Successful Design, Conduct, and Analysis

Demos Medical, 2010. — 396 p. — ISBN: 978-1933864389.Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial.Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials.Introduction: What Is a Clinical Trial?
Historical Perspectives of Oncology Clinical Trials
Ethical Principles Guiding Clinical Research
Preclinical Drug Assessment
Formulating the Question and Objectives
Choice of Endpoints in Cancer Clinical Trials
Design, Testing, and Estimation in Clinical Trials
Design of Phase I Trials
Design of Phase II Trials
Randomization
Design of Phase III Trials
Multiple Treatment Arm Trials
Noninferiority Trials in Oncology
Bayesian Designs in Clinical Trials
The Trials and Tribulations of Writing an Investigator Initiated Clinical Study
Data Collection
Reporting of Adverse Event
Toxicity Monitoring: Why, What, When?
Interim Analysis of Phase III Trials
Interpretation of Results: Data Analysis and Reporting of Results
Statistical Considerations for Assessing Prognostic Factors in Cancer
Pitfalls in Oncology Clinical Trial Designs and Analysis
Biomarkers and Surrogate Endpoints in Clinical Trials
Use of Genomics in Therapeutic Clinical Trials
Imaging in Clinical Trials
Pharmacokinetic and Pharmacodynamic Monitoring in Clinical Trials: When Is It Needed?
Practical Design and Analysis Issues of Health Related Quality of Life Studies in International Randomized Controlled Cancer Clinical Trials
Clinical Trials Considerations in Special Populations
A Critical Reader’s Guide to Cost-Effectiveness Analysis
Systemic Review and Meta-Analysis
Regulatory Affairs: The Investigator-Initiated Oncology Trial
The Drug Evaluation Process in Oncology: FDA Perspective
Industry Collaboration in Cancer Clinical Trials
Defining the Roles and Responsibilities of Study Personnel
Writing a Consent Form
How Cooperative Groups Function
Adaptive Clinical Trial Design in Oncology
Where Do We Need to Go with Clinical Trials in Oncology?