The analysis of a sequential clinical trial for the comparison of two lung cancer treatments

Abstract

Methods adopted in the analysis of data from a randomized controlled trial of a new treatment for inoperable lung cancer are described. The trial design employed the sequential logrank test using length of survival from time of randomization as the principal outcome measure. We describe the practical arrangements for regular inspections of the accumulating data as required by the sequential design, and also for more extensive but less formal interim analyses, and present some of the results. On termination of the trial the survival patterns of the two treatment groups were compared using methods of analysis developed specifically to allow for the sequential nature of the trial design. The role of prognostic factors was investigated using fixed sample methods which are approximately independent of the sequential design.