Therefore, we implemented the proposed group sequential design for HCTs ( Wu and Xiong, 2016) by using Lan-DeMets error spending function approach. The advantages of the error spending function methodology are the flexible choice of the error spending functions and user-friendly software, such as East 5 (2007) and the R package available for the implementation of trial designs. However, the popular group sequential methodology that uses error spending functions to generate efficacy and futility boundaries for interim monitoring has not been applied to HCT designs. (2007) and Wu and Xiong (2016) developed a multistage group sequential procedure for monitoring HCTs with survival endpoints. (1999) proposed a two-stage design for binary outcomes, and Xiong et al. Few studies have discussed the monitoring of clinical trials that use historical controls. Monitoring clinical trials with historical controls poses the statistical issue of comparing two outcomes in a situation in which data from the experimental group are sequentially collected and all data from historical controls have been collected at each interim analysis. HCTs are often monitored by interim analysis to stop accrual when outcomes of treated patients are worse than those in the historical control group. (2007) proposed sample size calculations for HCTs that take into account the uncertainty in the true historical control treatment effect. However, Korn and Freidlin (2006) showed that these methods do not preserve power if uncertainty in historical control data is considered. (2016) for exponential survival endpoints. Sample size calculations for HCTs have been discussed by Makuch and Simon (1980) for binary endpoints and by Dixon and Simon (1988), Emrich (1989), and Zhou et al. HCTs are widely used in clinical research. Therefore, HCTs are useful for studies with limited patient populations. ![]() The major benefit of HCTs is that all patients can receive the new treatment with historical data providing the information for the control arm. However, historical control trials (HCTs) are an alternative to RCTs if randomization is not feasible because of ethical concerns, patient preference, limited patient populations, or regulatory acceptability. Randomized clinical trials (RCTs) are considered the gold standard for clinical trials comparing treatment groups.
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