Next-gen digital health innovation in clinical trials

The Next Horizon of Digital Clinical Trials

Digital transformation of clinical trials is already underway. Rather than doing the same things more efficiently vanguard companies are looking for ways to use technology to do things differently. Some of these solutions are right around the corner, while others are further off. Below are some of the most exciting developments we are tracking in the space:

  • Replace traditional control arms with synthetic control arms or digital twins
    Traditionally, control groups in randomized controlled trials will receive a placebo or the current therapy considered standard-of-care to serve as a comparison for the intervention under investigation. However, the use of traditional control groups has raised ethical questions especially for debilitating conditions such as cancer or rare disease, or when the standard of care has limited efficacy. One alternative is synthetic control arms which use historic data or real-world evidence as opposed to traditional control arms. One digital health startup, UnlearnAI, is taking the idea a step further with their machine learning platform DiGenesis that builds “digital twins.” In this context, digital twins are comprehensive, longitudinal, and computationally generated clinical records that describe what would have happened if a patient had received a placebo.

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Why can’t we agree on how to define digital twins in healthcare?

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Summary of the EMA September 2022 Qualification Opinion for PROCOVA™

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Charles Fisher, Unlearn.AI: “now is the time to adopt AI-based solutions”

The potential for AI implementation in healthcare can barely be measured, as it can already do what humans do, just countless times better and more efficiently.
The European Medicines Agency has qualified Unlearn’s AI-powered method for running smaller, faster clinical trials.
Digital twins seem to be everywhere in healthcare now, but no one agrees on a single definition for them.