Use of Logrank Tests and Group Sequential Methods at Fixed Calendar Times

Abstract

This paper presents simulations to determine the operating characteristics of several group sequential boundaries when applied to the repeated analysis of survival data at equal intervals of calendar time. Because the group sequential boundaries of Pocock (1977, Biometrika 64, 191-199) and O'Brien and Fleming (1979, Biometrics 35, 549-556) were constructed on the assumption that each interim analysis provides an equal increment of statistical information, these boundaries are not theoretically appropriate for interim analysis at prescheduled calendar times. Nonetheless, our simulations show that these boundaries yield size and power near nominal levels for repeated logrank analyses at equal intervals of calendar time.