Few Game-Based Health Trials Outside the United States Post Their Results to the Public Registry

MIAMI, October 13, 2026 — Clinical trials that test video games, serious games, exergames, or gamified programs as health interventions are completed as reliably as other behavioral trials, but those run outside the United States rarely post their results to the public registry, according to a study of 1,785 trials registered on ClinicalTrials.gov published in OnScientia – International Journal of Business, Law & Health. Among eligible trials, 39.8 percent of those with a United States site had posted results, against 2.1 percent of those with sites only in other countries.

Game-based treatments have entered regulated care: in June 2020 the United States Food and Drug Administration (FDA) authorized the first game-based digital therapeutic, and reimbursement pathways for digital health applications now exist, for example in Germany.

The study, Registered Game-Based Health Trials — Completion and Results Reporting on ClinicalTrials.gov by Dimitar Gyaurov, is a cross-sectional analysis of registry records retrieved on September 23, 2026. Of 2,073 records returned by a search for game terms, 1,785 met the screening rule, applied through a large-language-model pre-classification, a partial review by the author, and a reliability check by an independent rater. The trials were compared with 59,770 behavioral trials on the same registry.

Registrations rose from an average of 48 a year in 2012–2016 to 176 a year in 2021–2025. The trials are small, with a median registered enrollment of 60 participants, and 91.7 percent are led by academic, hospital, nonprofit, or individual sponsors. Of those completed, terminated, or withdrawn, 6.3 percent were terminated or withdrawn, against 7.0 percent of behavioral trials.

Among trials that ended at least 12 months before data collection, 13.5 percent had posted results, against 15.6 percent of behavioral trials, and the adjusted comparison showed no significant difference (odds ratio 1.01, 95 percent confidence interval 0.78 to 1.30). Within the game-based sample, 92 of 231 trials with a United States site had posted, against 11 of 525 with sites only elsewhere. The share of game-based trials with a United States site fell from 49.0 percent of those first registered in 2007–2015 to 19.6 percent in 2021–2026.

The author identifies the reach of United States rules as a plausible explanation. Federal law requires results posting for applicable trials of products regulated by the FDA, and a National Institutes of Health policy extends results reporting to the trials the agency funds; neither reaches trials conducted elsewhere without United States product applications or funding. The study notes that institutional practice may also play a part.

The study measures posting in the registry, not publication, so trials without registry results may have reported them in journals or national registries. Only ClinicalTrials.gov was searched, and the associations reported are not causal.

The study concludes that the clinical evidence base for game-based interventions is being generated and completed but, outside the reach of United States reporting rules, is rarely disclosed in the registry.

The full study is published in OnScientia – International Journal of Business, Law & Health.

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