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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Webinars

Part 3: Innovation in Clinical Research: AI-based Drug Development Tools and the Regulatory Landscape‍

Webinars

Part 2: Faster, More Efficient Trials: Novel Trial Designs using Digital Twins‍

Webinars

Part 1: AI, Digital Twins, and the Future of Clinical Research‍

Learn about how Digital Twins are created and how they are incorporated into clinical trials to increase power, accelerate timelines, and enable patient level insights.
Watch an overview of specific use cases for Digital Twins and learn how novel trial designs with Digital Twins enable smaller trials that maintain their power.
Watch a panel discussion on the regulatory landscape where experts share perspectives on the future of AI-based drug development tools like Digital Twins.