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In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Joel Morse, CEO and co-founder of Curavit Clinical Research, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), for a discussion on why it is that digital therapeutics (DTx) are effective and safe, but not being prescribed.

A virtual contract research organisation (vCRO), 2020-founded Curavit specialises in decentralised clinical trials (DCTs) for DTx, while the DTA works to enable expanded access to high-quality, evidence-based DTx for patients, clinicians, and payors in order to improve clinical and health economic outcomes and provide the digital health ecosystem with the necessary tools to define, evaluate, and utilise DTx products.

Doctors once trying to use fax machines to provide one of the most advanced technologies in the industry, Molnar explains the passion that propels him in his work, and Morse describes Curavit’s latest Health Economics and Outcomes Research (HEOR) practice for pharmaceutical clinical trials, collecting endpoint data to prove medical value, capturing insurance claims and medical record data, the latter quantifying the spending necessary, as undertaken in a recent MedRhythms trial.

Getting the data together to prove to all key stakeholders to adopt these products is quite complex, Molnar says. To provide a new technology, it has to be believable to the broad population and the providers that give care. Indeed, Morse states there is a lack of understanding in the healthcare ecosystem when it comes to DTx.

A lot of the time, the biggest challenge is finding a principal investigator (PI) that has exposure to Software as a Medical Device, for instance. There is a material effort to educate the ecosystem on providing a new genre of healthcare, therefore, and the medical community in the US is a learning community. The conversation also considers the European scenario in passing.

It’s not good enough to just show efficacy, economic value needs to be shown, in DTx and across the board.

You can listen to episode 105a of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series in iTunes, Spotify, acast, Stitcher, and Podbean.

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