Fundamental concepts for new clinical trialists. (2015)

• Record Type: Book
• Further Information: Note: Scott Evans, Naitee Ting.
• Authors: Evans, Scott R; Ting, Naitee
• Contents: 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® Drug Label Index References appear at the end of each chapter.
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2015
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.70724; Clinical trials -- Statistical methods; Mathematical statistics
• Languages: English
• ISBNs: 9781498767101
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.