One essential step to introduce a novel pharmaceutical - or even
to begin selling a generic compound - is to establish that the drug as packaged and sold will
have acceptable safety and efficacy profiles.
This is done using clinical trials.
When evaluating these compounds in a clinical trial, both outcomes are possible:
\begin{enumerate}
\item The compound demonstrates sufficient safety and efficacy, and proceeds in the appoval process. \ref{Item:EndSuccess}
\item The compound fails to demonstrate sufficient safety and efficacy, and the approval process halts. \ref{Item:EndFail}
\item The trial is terminated before it can acheive one of the first two outcomes, for reasons unrelated to safety and efficacy concerns. \label{Item:Terminate}