Tracing Digital Therapeutics Research Across Medical Specialties: Evidence from ClinicalTrials.gov.

Autor: Masanneck L; Department of Neurology, Medical Faculty University Hospital Düsseldorf, Düsseldorf, Germany.; Digital Health Cluster, Hasso-Plattner Institute, Potsdam, Germany., Stern AD; Digital Health Cluster, Hasso-Plattner Institute, Potsdam, Germany.; Technology and Operations Management Unit, Harvard Business School, Boston, Massachusetts, USA.; Harvard-MIT Center for Regulatory Science, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Jul; Vol. 116 (1), pp. 177-185. Date of Electronic Publication: 2024 Apr 02.
DOI: 10.1002/cpt.3260
Abstrakt: Digital therapeutics (DTx), evidence-based software interventions for preventing, managing, or treating medical disorders, have rapidly evolved with healthcare's shift toward online, patient-centric solutions. This study scrutinizes DTx clinical trials from 2005 to 2022, analyzing their growth, funding, underlying medical specialties, and other R&D characteristics, using ClinicalTrials.gov data. Our analysis includes trials categorized via the ICD-11 system, covering active, recruiting, or completed studies and considering trials listing multiple conditions. In analyzing 5,889 registered DTx trials, we document a more than five-fold increase in such trials since 2011, and a compound annual growth rate of 22.82% since 2005. While most trials were single-center, the median number of study subjects increased in recent years, driven by larger interventional trials. The key disciplines driving this growth were psychiatry, neurology, oncology, and endocrinology. Mental health dominated DTx trials in recent years, led by neurocognitive disorders, substance abuse disorders, and mood disorders. Industry funding varied across disciplines and was particularly high in visual system diseases and dermatology. DTx trials have surged since 2005, accelerated by recent growth in mental health trials. These trends mirror developments toward remote healthcare delivery, amplified by digital health investments during the COVID-19 pandemic. Growing numbers of participants in DTx trials point to increased demand for more robust trials. However, because most trials are single-center and country-specific, more international cooperation and harmonized evaluation standards will be essential for DTx trials to become more efficient and provide validation across countries, health systems, and groups of individuals.
(© 2024 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)
Databáze: MEDLINE
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