“…Rather, we want to do surveillance to monitor for an inherent safety problem that is always present in the drug rather than detecting a suddenly occurring safety problem due to, for example, a manufacturing problem in a new batch of the drug. Sequential probability ratio tests have been extended and refined in various ways, including Bayesian approaches (Lechner, 1962;Peskir and Shiryaev, 2000), and both the theoretical and practical aspects of the field have been summarized in excellent books by Ghosh et al (1997), Jennison and Turnbull (2000), de Silva (2009), andGovindarajulu (2004), among others. Particularly relevant to this article are efforts to deal with composite alternatives in various settings such as binomial proportions (Hoel et al, 1976;Joanes, 1972;Meeker, 1981), normally distributed data (Lachin, 1981;van der Tweel et al, 1996), Poisson data (Abt, 1998), variance components (Ghosh, 1965), functions of unknown parameters (Bangdiwala, 1982), as well as more general models using asymptotic optimality (Lai, 1988;Schwarz, 1962), stepwise sequential probability ratio tests (Huang, 2004), cost functions (Holm, 1985;Schipper et al, 1997), or various approaches that reduce composite hypotheses to simple hypotheses (Ghosh, 1970;Lai, 2001;Wald, 1947).…”