White Paper Accrual Modeling and Adaptive Trial Monitoring with IQVIA Trial Designer
IQVIA's Trial Designer (ITD) is a web-based system that offers a wide range of adaptive clinical trial design options, statistical models, and simulations for both established and novel trial designs. ITD's group-sequential module and accrual simulations enable collaboration among multiple users and streamline the trial design process.
ITD's dose-escalation module allows for the design of dose-ranging studies, while its adaptive group-sequential designs enable the use of early stopping rules based on efficacy or futility. ITD's spending functions and sample size re-estimation modules enable the prediction of recruitment and endpoint collection, and the model-based accrual monitoring module allows for the prediction of patient accrual.
ITD's technical specifications include a user-friendly interface, real-time data visualization, and seamless integration with other systems. ITD's case study showcases the use of adaptive design with accrual monitoring, and demonstrates the benefits of using ITD's spending function approach, early stopping for efficacy, early stopping for futility, and sample size re-estimation approach.
ITD's group-sequential approach allows for the use of multiple sites and piece-wise recruitment rates, and its events accrual monitoring module allows for the use of piece-wise hazard rates. ITD's direct accrual calculation and simulation results provide a comprehensive approach to trial design, and enable the prediction of patient accrual in a variety of scenarios.
In conclusion, ITD's group-sequential approach and accrual simulations enable the development of novel trial designs, and provide a comprehensive approach to trial design that can be used to address the issue of effect size not being well defined before the trial for new therapeutics.
