WHITE PAPER
IQVIA Trial Designer
Accrual Modeling And Adaptive Trial Monitoring
Nov 02, 2023
Adaptive clinical trial designs can be used to address the issue of effect size not being well defined before the trial for new therapeutics. When these types of trial designs are combined with models and simulations for the accrual process, it is possible to predict the development of recruitment and endpoint collection and adjust strategy based on interim analysis results.

We describe IQVIA Trial Designer (ITD), a modern complex user-friendly web-based system that offers a broad range of such design options, statistical models and simulations that statisticians can use for fast exploration and development of both established and novel trial designs. Moreover, ITD facilitates collaboration among multiple users and streamlines the trial design process.

To showcase the group-sequential module and the use of accrual simulations, in this paper we consider an example with adaptive design with time-to-event endpoint and the underlying issues. The accrual module includes a novel approach to accrual simulations on various levels of granularity that are useful in the design phase as well as for trial monitoring and adaptation.

A twin paper Dose-finding in early clinical trials with IQVIA Trial Designer is also available.

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