Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods

1.3 Emergence of Group Sequential Designs in the 70s and 80s

While the theory of group sequential design dates back to 1969, actual application began in the 1970s [18,19]. Canner notes the early evolution of applying multiplicity-adjusted analyses along with an external monitoring board in the Coronary Drug Project (CDP) [20]. For the first two years of CDP, investigators were informed of interim data by treatment group. Subsequently, perhaps the first external data and safety monitoring committee (DSMC) was formed to be the only reviewers of data summary by treatment group for the remainder of the trial. This trial also had what we now might call an executive committee (termed the CDP Policy Board then) that was charged with acting on DSMC recommendations. ...