Clinical Evaluation of Digital Therapeutics: Present and Future
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Objectives: Digital therapeutics (DTx) are software-based therapeutic interventions based on clinical evidence. Randomizedclinical trials (RCTs) are often the source of clinical evidence, similar to conventional drugs or medical devices. However,novel approaches such as the use of real-world data or digital biomarkers are also utilized. This article aimed to review howDTx products have been clinically evaluated. Methods: DTx products approved by the US Food and Drug Administrationas of 2020 were reviewed and products with sufficient published information were selected. Pivotal clinical trials were analyzedaccording to the elements of the Consolidated Standards of Reporting Trials (CONSORT) guideline. Case reviews werepresented for other clinical evaluation strategies, considering the small number of publications. Results: Most approved DTxproducts used RCTs for clinical evaluations. Similar to conventional RCTs, parallel-group designs with statistical hypothesistesting were adopted. However, DTx trials were often not blinded due to practical issues and involved various comparatorgroups. In addition, DTx products could be readily evaluated in home-based settings and delivered through the internet. Other evaluation approaches included retrospective analyses using insurance claims data or usage data, which enabled longtermevaluations of effectiveness. Digital biomarkers obtained from real-time and continuous log data were also used to improvethe objectiveness of endpoints. Conclusions: RCTs accounted for the majority of DTx evaluations. The designs of DTxtrials were comparable to those of drug or device trials, but blinding and comparator elements were often different. Furthermore,the use of real-world data and digital biomarkers are also being tried.
Abstract
Objectives: Digital therapeutics (DTx) are software-based therapeutic interventions based on clinical evidence. Randomizedclinical trials (RCTs) are often the source of clinical evidence, similar to conventional drugs or medical devices. However,novel approaches such as the use of real-world data or digital biomarkers are also utilized. This article aimed to review howDTx products have been clinically evaluated. Methods: DTx products approved by the US Food and Drug Administrationas of 2020 were reviewed and products with sufficient published information were selected. Pivotal clinical trials were analyzedaccording to the elements of the Consolidated Standards of Reporting Trials (CONSORT) guideline. Case reviews werepresented for other clinical evaluation strategies, considering the small number of publications. Results: Most approved DTxproducts used RCTs for clinical evaluations. Similar to conventional RCTs, parallel-group designs with statistical hypothesistesting were adopted. However, DTx trials were often not blinded due to practical issues and involved various comparatorgroups. In addition, DTx products could be readily evaluated in home-based settings and delivered through the internet. Other evaluation approaches included retrospective analyses using insurance claims data or usage data, which enabled longtermevaluations of effectiveness. Digital biomarkers obtained from real-time and continuous log data were also used to improvethe objectiveness of endpoints. Conclusions: RCTs accounted for the majority of DTx evaluations. The designs of DTxtrials were comparable to those of drug or device trials, but blinding and comparator elements were often different. Furthermore,the use of real-world data and digital biomarkers are also being tried.
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