Fundamentals of Clinical Trials

• Main Authors: Friedman, Lawrence M. (Author), Furberg, Curt D. (Author), DeMets, David L. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2010.
• Edition: Fourth.
• Subjects: Statistics.; Oncology.; Public health.; Epidemiology.; Statistics for Life Sciences, Medicine, Health Sciences.; Public Health.; Cancer Research.
• Online Access: https://ezaccess.library.uitm.edu.my/login?url=http://dx.doi.org/10.1007/978-1-4419-1586-3

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added...

Table of Contents:

• Introduction to clinical trials
• Ethical issues
• What is the question?- Study population
• Basic study design
• The randomization process
• Blindness
• Sample size
• Baseline assessment
• Recruitment of study participants
• Data collection and quality control
• Assessing and reporting adverse effects
• Assessment of health-related quality of life
• Participant adherence
• Survival analysis
• Monitoring response variables
• Issues in data analysis
• Closeout
• Reporting and interpreting of results
• Multicenter trials.