WHITE PAPER
Dose-Finding in Early Clinical Trials with IQVIA Trial Designer
Dose-finding is the primary goal of early clinical trials. Traditionally, the main aspect has been to consider safety but recently there is a shift to include the efficacy criteria early on
May 12, 2023

Dose-finding is the primary goal of early clinical trials. Traditionally, the main aspect has been to consider safety but recently there is a shift to include the efficacy criteria early on. This requires trial designs that go beyond the straightforward 3+3 method and typically use and benefit from simulations in the design phase.

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

To showcase the dose-escalation module, in this paper we consider a dose escalation example that uses both toxicity and efficacy endpoint and discuss two approaches and underlying issues. The first approach uses an established PRINTE design and the second one a novel two-parameter BOIN-based design.

Related solutions

Contact Us