Fundamentals Of Clinical Trials

These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure. This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women’s health and screening tests. In these studies