Rise of Clinical Studies in the Field of Machine Learning: A Review of Data Registered in ClinicalTrials.gov

Abstract

Although advances in machine-learning healthcare applications promise great potential for innovative medical care, few data are available on the translational status of these new technologies. We aimed to provide a comprehensive characterization of the development and status quo of clinical studies in the field of machine learning. For this purpose, we performed a registry-based analysis of machine-learning-related studies that were published and first available in the ClinicalTrials.gov database until 2020, using the database's study classification. In total, n = 358 eligible studies could be included in the analysis. Of these, 82% were initiated by academic institutions/university (hospitals) and 18% by industry sponsors. A total of 96% were national and 4% international. About half of the studies (47%) had at least one recruiting location in a country in North America, followed by Europe (37%) and Asia (15%). Most of the studies reported were initiated in the medical field of imaging (12%), followed by cardiology, psychiatry, anesthesia/intensive care medicine (all 11%) and neurology (10%). Although the majority of the clinical studies were still initiated in an academic research context, the first industry-financed projects on machine-learning-based algorithms are becoming visible. The number of clinical studies with machine-learning-related applications and the variety of medical challenges addressed serve to indicate their increasing importance in future clinical care. Finally, they also set a time frame for the adjustment of medical device-related regulation and governance.

Keywords: ClinicalTrials.gov; device regulation; digital health; machine learning; registry analysis.

Figure 1

Flowchart for the selection procedure of the ML-related clinical study entries considered for the quantitative registry analysis. Source: Own figure based on the evaluation of the ClincalTrials.gov dataset [36].

Figure 2

Number of clinical studies related to ML by year of publication on ClinicalTrials.gov (n = 358). Source: Own figure based on the evaluation of the ClincalTrials.gov dataset [36].

Figure 3

Study entries in the field of ML by study-initiating medical specialty/field (n = 358). Source: Own figure based on the evaluation of the ClincalTrials.gov dataset [36]. * Dianostic Radiology/Biomedical Imaging, Radiation Oncology, Nuclear Medicine.