Incorporating External Control Arms into Clinical Trials

The ideal drug clinical trial is efficient with recruitment, has high statistical power to detect relevant effect sizes, and enables regulators and clinicians to make confident decisions about whether the new treatment should be given to patients. Patient recruitment barriers, as well as pressure to run trials faster and at lower costs, have led organizations to look for alternative ways to run well powered trials. To increase power, two different approaches to incorporating external data into trials are gaining momentum: Synthetic Control Arm (SCAs) and Digital Twins. In this whitepaper, we provide an overview of SCAs and Digital, their respective statistical techniques, and effects on trial operating characteristics. Although both approaches increase power, unlike SCAs, Digital Twins do not increase sample size and are robust to known and unknown founders. 

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How Digital Twins make it possible to design and run more efficient clinical trials with well-defined statistical properties.