AI digital twins could replace control arm in clinical trials

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A new study demonstrates that AI-powered digital twin solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial.

The paper was co-authored by analytics company Phesi and Dr Yi-Bin Chen, Director for the Blood and Marrow Transplant Program at Massachusetts General Hospital.

Phesi created a digital twin for chronic graft versus host disease (cGvHD) in the primary treatment setting.

The digital twin was developed to replicate patients receiving prednisone, the first-line treatment currently used as the standard-of-care for cGvHD, and commonly used in control arms of prospective clinical trials.

A total of 2,042 patients (32 cohorts) with cGvHD were selected and used to construct the first-line therapy (fl)GvHD digital twin cohort and 438 patients from eight cohorts were used to construct the flGvHD digital twin standard-of-care cohort.

“Digital twins can support the industry to overcome longstanding challenges faced in patient recruitment, the ethical issues associated with placebo arms, and the impact these constraints have on cycle and approval times,” said Dr Gen Li, President, Phesi. “We have demonstrated that digital twins offer real potential to replace standard-of-care comparator arms to streamline the implementation of clinical trials and dramatically reduce patient burden.”

Corticosteroids are the front-line treatment for cGvHD, but the long-term effects of corticosteroids combined with the chronic nature of the condition has highlighted the urgent need for alternative treatments.

“When half of trial participants must be assigned to a control arm, clinical trial accrual is oftentimes difficult,” explained Dr Yi-Bin Chen, co-author and Director for the Blood and Marrow Transplant Program at Massachusetts General Hospital. “This digital twin would allow clinical researchers to accelerate clinical trials into this challenging condition by automating an external control arm and allowing sponsors to test new therapies faster.”

Diana Spencer, Senior Digital Content Editor, DDW

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