Article | October 8, 2019

Digital Therapeutics And Virtual Trials: An Ideal Match

By Katy Preciado, senior clinical project manager, IQVIA Virtual Trials

IQVIA_Senior man checking his smartphone

Digital therapeutics are pushing healthcare’s transformation, melding advanced science and technology into a new realm of patient care. And pharma leaders are embracing this evolution.

In 2017, Pear Therapeutics’ reSET app became the first prescription digital therapeutic for disease treatment to be cleared by the US Food and Drug Administration (FDA). The app, which is designed for the treatment of substance use disorders, provides patients with cognitive behavioral therapy to help them track, manage and mitigate their cravings and triggers.

A year later, FDA granted clearance for reSET-O, Pear’s cognitive behavior therapy app for patients with opioid use disorder (OUD). This prescription-only mobile app is intended to increase retention of patients with OUD in outpatient treatment who are taking prescribed medication. Pear is partnering with Sandoz, a division of Novartis, to commercialize the two products.

That same year, FDA also approved Natural Cycles, an app to help prevent pregnancy, making it the first “digital contraception” device to receive regulatory clearance. The app boasts a 98 percent rate of effectiveness with perfect use, and 93 percent with “typical use.”

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