10.1 Introduction

10.1.1 Randomized Clinical Trials

The most common goal of a randomized clinical trial (RCT) is to compare the effects of one or more experimental treatments versus control treatment (standard of care) in the target patient population. Randomization plays a fundamental role in the RCT design. By introducing a deliberate element of chance into the assignment of treatments, one increases the likelihood that important patient characteristics (known and unknown) that may affect the outcome of interest are similarly distributed across the treatment groups, and therefore, any observed treatment difference should be attributed to the treatment effects, not the effects of study patients [1]. Importantly, randomization by itself is not ...

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