Beyond placebo purism: rebalancing evidence standards for digital therapeutics

Digital therapeutics (DTx) are increasingly evaluated using evidentiary frameworks derived from pharmacological trials, including calls to treat placebo-controlled designs as an ethical gold standard. Responding to Druart and Blease, we argue that this framing misaligns evidentiary expectations with the distinctive characteristics of digital interventions. Because many DTx function as complex behavioural interventions, credible placebo comparators are often difficult or artificial to construct. Ethical evaluation should therefore also consider minimal clinically important differences (MCIDs), real-world evidence (RWE) and proportionality of evidence to risk. Emerging regulatory models illustrate how rigour can be distributed across the product lifecycle through staged evaluation and post-market evidence generation. Placebo controls should thus be viewed as one methodological option among several rather than an ethical litmus test for digital health trials.