Prognostic digital twins overcome the limitations of external control arms in RCTs

Drug developers facing barriers to patient recruitment and pressure to run trials faster have sought out methods that allow for smaller control arms in randomized controlled trials. Such methods that take advantage of the large quantity of existing patient data from previously completed clinical trials are desirable not only for reducing trial sizes but also for honoring the valuable contributions of past trial participants.

Both digital twins and external control arms incorporate external data into clinical trials, but they are very different methods with different aims. This whitepaper will review how each of these two approaches reduces trial sizes, but only digital twins overcome the issues of confounding variables and bias.

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