Info

s |O'Brien-Fleming|

s |O'Brien-Fleming|

|Haybittle-Petol

Pocock

Analysis Number figure 8.1. Different types of stopping boundaries for monitoring a Phase III trial. The upper and lower boundaries represent statistical test values on the vertical axis (on a standard normal scale), which, if exceeded at a given analysis indicated on the horizontal axis, would prompt stopping of the trial (the fourth analysis is the definitive analysis at the predetermined requisite number of events). The horizontal lines at ±1.96 represent the standard P greater than 0.05 boundary. Note that the Pocock boundary uses a fixed, modestly more extreme value, but the final test result must then also be more extreme than the conventional 0.05 test to be considered significant. The Haybittle-Peto method uses a conventional final test value but is very conservative through the penultimate hypothesis test. The O'Brien-Fleming boundaries begin very conservatively, but change as more information accrues, and also allow that the final test be performed using the conventional significance level.

TABLE 8.5. Prototypical Phase III trial data and safety monitoring

committee.

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