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<p>We aimed to describe the totality of evidence for United States Food &amp; Drug Administration (FDA)-authorized digital therapeutics (DTx). We identified FDA-authorized DTx with a decision from 2019-2022, then identified studies evaluating these DTx. For the initial indication of each DTx, we classified: 1) development/pilot studies; 2) pivotal randomized controlled trials (RCTs); and 3) real-world evidence [RWE]/post-market studies. We separately grouped all studies assessing DTx indication expansion/product modifications. For 45 DTx, we identified 436 studies (median 7, range 0–73 per DTx), spanning over 2 decades (2001–present). The totality of evidence varied from extensive evidence dossiers, with studies from each category for 31.1% DTx, to none for 11.1%. Half (46.7% DTx) had a pivotal RCT. For 13.3% DTx, the lag between study start and/or publication and FDA-authorization was &gt;10 years; half (53.3%) had no available results prior to authorization. The totality of evidence for FDA-authorized DTx varied, reflecting the heterogeneity in DTx characteristics, development, regulation, and evaluation. Given some DTx entered the market with limited or no publicly available data, more transparent, timely dissemination of results and consistent evidence standards, appropriate to the level of risk of the individual DTx, are needed to inform clinical and regulatory decision-making.</p>

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Mapping the evidence supporting FDA-authorized digital therapeutics, before and after authorization

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月20日

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  • Melissa Amyx,
  • Farzaneh Alebouyeh,
  • Ngan Thi Thuy Phi,
  • Philippe Ravaud,
  • Viet-Thi Tran

摘要

We aimed to describe the totality of evidence for United States Food & Drug Administration (FDA)-authorized digital therapeutics (DTx). We identified FDA-authorized DTx with a decision from 2019-2022, then identified studies evaluating these DTx. For the initial indication of each DTx, we classified: 1) development/pilot studies; 2) pivotal randomized controlled trials (RCTs); and 3) real-world evidence [RWE]/post-market studies. We separately grouped all studies assessing DTx indication expansion/product modifications. For 45 DTx, we identified 436 studies (median 7, range 0–73 per DTx), spanning over 2 decades (2001–present). The totality of evidence varied from extensive evidence dossiers, with studies from each category for 31.1% DTx, to none for 11.1%. Half (46.7% DTx) had a pivotal RCT. For 13.3% DTx, the lag between study start and/or publication and FDA-authorization was >10 years; half (53.3%) had no available results prior to authorization. The totality of evidence for FDA-authorized DTx varied, reflecting the heterogeneity in DTx characteristics, development, regulation, and evaluation. Given some DTx entered the market with limited or no publicly available data, more transparent, timely dissemination of results and consistent evidence standards, appropriate to the level of risk of the individual DTx, are needed to inform clinical and regulatory decision-making.