ABSTRACT
In the United States, modern randomized controlled trials got their start in the early 1960s, supported by the National Institutes of Health. In the planning, monitoring and analysis of randomized controlled trials, there are a number of statistical concepts involved. Following the clinical questions to be addressed in terms of the clinical hypotheses and the objectives of the randomized controlled trials, these statistical concepts need to be developed in a logical and sequential manner. Invariably, randomized controlled trials are monitored for the safety of participants and efficacy of treatments or interventions under investigation. Interim analyses also offer the opportunity to evaluate the assumptions made during the planning for possible sample re-estimation and to introduce adaptive designs if desired. The chapter also presents an overview of the key concepts discussed in this book.
