Opis: Fundamental Concepts for Clinical Trial Statisticians - Scott Evans, Naitee Ting
Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.Background Clinical Trials Introduction Phases The Protocol Clinical Trial Registration Ethical Issues Product Development Process The Drug Label Nonclinical Development Clinical Development Regulatory Review Organizations Food and Drug Administration European Medicines Agency Guidances Clinical Trial Statisticians Roles of the Clinical Trial Statistician Important Attributes and Suggestions for Development Scientific and Practical Issues General Considerations in Clinical Trial Design General Design Issues in Clinical Trials Design Issues in Controlled Clinical Trials Special Issues Clinical Trial Designs Phase I Other Trial Designs Including Phase II and III Phase IV Interim Data Monitoring Data Monitoring Committees/Data Safety Monitoring Boards Interim Monitoring Methods Limitations and Extensions A Centralized Risk-Based Approach to Monitoring Analysis Considerations SAP Other Preparations for Analyses General Issues Report Writing Analysis of Safety, Benefit:Risk, and Quality of Life Safety Benefit:Risk Evaluation Quality of Life Publishing Trial Results Guidelines for Reporting Clinical Trial Results Reporting the Results of Subgroup Analyses Reporting Benefits and Risks Reporting NI Trials Reporting Adaptive Designs Reporting Bayesian Designs Appendix: Excerpts from the Lipitor(R) Drug Label Index References appear at the end of each chapter.