ABSTRACT
A clinical trial should have formal methods to address
and minimize these sources of systematic and random
uncertainty to ensure appropriate validity of the trial results.
These sources of uncertainty will be discussed in more
detail in section Systematic and Random Errors in Trial
Design. It is important for investigators to understand that
these sources of study error can be controlled by appropri-
ate and proper trial design but cannot be accounted for
subsequently by statistical analysis alone. Thus, it is critical
to have a well-designed clinical trial that addresses these
issues at the outset to ensure authenticity of trial outcomes.
