Abstract
This chapter discusses the origins, development, use, and current limitations of the terminal step in the drug development/approval process, namely the Randomized Prospective Clinical Trial. The methodological relationship between clinical trials and the basic science procedures leading up to the trials are explored, with particular emphasis on the transferred methodological limitations and constraints involved in moving from the bench to the bedside. The general procedures involved in performing a clinical trial are described, along with the intrinsic and logistical challenges that limit the application, interpretability, and extrapolation of clinical trials. We introduce the paradoxical relationship between the two predominant trends in clinical research, Evidence-Based Medicine and Personalized Medicine, and explore the fundamentally contradictory nature of these two trends.
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