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Simulation-Guided Design Is Reshaping Clinical Trial Strategy

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You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology Innovation, so let’s take a closer look at simulation-guided design and what it enables clinical trial sponsors to do.

There are numerous practical hurdles in clinical trial strategy development, and conventional trial design methods can greatly limit sponsors’ ability to select the most strategically, economically, and commercially viable design. By collaborating with statisticians and data scientists, trial sponsors can access new design opportunities via advanced digital design tools.

Simulation-based statistical design means simulating the data that might be observed based on the given assumptions. In the realm of clinical trial design, this can enable teams to pressure test the effects of a wide variety of scenarios quickly and easily with simulations. Sponsors can systematically test for what would happen if the team’s assumptions were imperfect, leading to a more de-risked and optimal trial design.

Our first 2023 Winter Weekend Read, Advancing Clinical Trials with Digital Tools: Simulation-Guided Design, by Yannis Jemiai, PhD, Albert Kim, MD, PhD, Joan Gaffney, MBA, and Esha Senchaudhuri, PhD, discusses how simulation-based statistical design can harness data to foresee risks, navigate uncertainties, align on internal goals, and produce pressure-tested clinical trial designs. The road map created allows trial strategists to avoid relying solely on conventional or familiar paths, and potentially missing the best route. And while simulation is an old tool, new technology is far more powerful and enables unparalleled insights.

It’s time to stop relying solely on conventional or familiar trial design methods – and potentially missing out on the best designs in the process. Download Advancing Clinical Trials with Digital Tools to learn more:


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The Winter Weekends Reads series features complimentary publications on a variety of topics on clinical trial design and data science. Subscribe to our weekly newsletter below and never miss a post!

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