Trial Performance Metrics TEST

TEST Trial performance metrics refers to quantities such as probability of achieving the target value (PTV), probability of making correct decisions (POCD) and probability of success (POS) for a proposed trial. Such performance metrics evaluate the performance of the drug in the context of a proposed clinical trial design. In contrast, standard power calculations focus on the performance of the design at an assumed treatment effect size for a planned type I error; however, standard operating characteristics such as power do not provide information as to how likely the compound can achieve the assumed treatment effect. It is recommended that clinical trial simulations be routinely implemented quantifying PTV, POCD and POS throughout drug-development particularly at key drug development milestones.