Fig. 1.

Mitigating risk of failure in phase III.

Various elements culminating in the design and execution of a phase III trial can heavily influence the probability of success. Each of these aspects, depicted by colored circles, are associated with varying degrees of difficulty, measured by cost, time and scale. Each also differentially contributes to the predictivity of success in a phase III program. While one can never be certain that the primary endpoint will be met, the more of these critical elements are satisfied, the more predictable an outcome will be (multicolored circle).

PBO, placebo; RCT, randomized controlled trial.