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PDT Studies: The Positives, the Shortcomings — and Getting the Good Parts ‘Packaged Together’

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The corresponding author of a study published in Health Affairs of the research supporting 20 FDA-authorized prescription digital therapeutics (PDTs) sees some positives but also an overall lack of rigor and the need for at least one high-quality clinical trial for each PDT.

When Sanket S. Dhruva, M.D., M.H.S., and his colleagues sifted through over 100 studies of the 20 FDA-authorized prescription digital therapeutics (PDTs), they found plenty of studies with some of the notable attributes of high-quality research.

All of the PDTs had, for example, one of more supporting studies with a clinical primary end point, and 18 were evaluated in at least one randomized controlled trial.

But Dhruva and his colleague also found that only two of the 20 PDTs they studied had a supporting study that met the criteria for studies that provide reliable evidence. They reported their results in the November issue of Health Affairs.

"It's important to conduct a randomized trial, in multiple centers, that has, ideally, double blinding, as well as the demographic factors that includes diverse patients. We found that all of those [weren't] as packaged together as often as we'd like to see in order to consider the evidence as reliable — as sturdy as possible — to have causal inference — that is, does the prescription digital therapeutic do what it is intended to do."

Dhruva continued “I think there are lots of positives. I’d like to see those packaged together more often so that we have at least one rigorous robust study.”

Whether PDTs are effective has to be decided on a case-by-case basis, said Dhruva, adding the comment that “in general I would have more confidence overall in prescription digital therapeutics if I had seen a more rigorous base.”

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