Clinical Trial Question: Introduction
 
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A clinical trial is designed to answer a simple question:

Does the new experimental treatment allow patients to achieve a better clinical outcome than a control treatment?

 

The question defines the important elements of trial design.
One must select the:

  • Patient Population
  • Trial Endpoint
  • Desirable Treatment Difference
  • Control Treatment

The control treatment can be a placebo and/or one or more approved active drugs. In this course, we will use the term "drug" to apply to both small molecules and biologics. The individuals designing the trial must also decide how certain they want to be of the answer by selecting the power and false positive rate alpha.

Now let's discuss each of these trial design elements.