Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization

Background: Decentralized clinical trials (DCTs) that are not dependent on patient visits at clinical trial sites attract attention from the pharmaceutical industry due to the currently ongoing pandemic, as they reduce the burden on study participants and improve patient engagement in clinical studies. To understand the trend of usage of DCT components in clinical studies, this study aimed to grab the comprehensive landscape of DCTs and identify their remarkable aspects for promoting DCT implementation by analyzing the data extracted from a clinical trial database.Methods: The ClinicalTrials.gov database was used to determine the trend in clinical trials of DCTs. The data of clinical trials were extracted using the selected DCT-specific keywords. The extracted data were categorized by study phase, start year, sample size, and DCT components.Results: In total, 543 studies were identified and analyzed per various characteristic elements. The number of studies that implemented DCT components like telemedicine, home healthcare, direct-to-patient, and IoHT was increasing annually and exponentially increasing in 2020, the year of the COVID-19 pandemic. For further investigations of the trend of DCT usage in drug/device development, 76 of the 543 studies were selected. Moreover, the number of multiregional clinical trials applying DCT components was limited (9.2%).Conclusions: A high number of DCTs were conducted and the number of studies increased at the timing of the COVID-19 outbreak. However, globally, DCTs are not used commonly. Our comprehensive study provides an in-depth understanding of DCT implementation in clinical trials for drug and device development.