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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.
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.
Change the model of clinical research by integrating data, expertise, analytics and technology from study design through execution to power better decisions.
Improve the performance of your clinical trials with the power of the IQVIA CORE.
Getting the right outcomes from your clinical trials is all about the data and insights they provide. Biostatistics in clinical trials isn’t just a necessity, it can be a real competitive advantage.