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

Managed Healthcare Executive November 17, 2023
Peter Wehrwein, Managing Editor

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...

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