Digital Therapeutics and Decentralized Clinical Trials Optimization in an Era of Increasing Complexities

Abstract

Clinical trials typically revolve around three models: traditional,
virtual, and decentralized trials. In traditional clinical research,
data collection and data capture happen onsite. Virtual trials are
fully remote (i.e., remote monitoring) where enrollment happens at
a distance. Moreover, Decentralized trials happen when both the
data collection and data capture occur outside of the traditional
site.According to Naveen Dha in “What is a Decentralized Clinical
Trial (DCT),” DCT can “either be fully remote or adopt a hybrid approach
where some physical-site attendance is required. They are achieved with
the use of remote monitoring and diagnostics, home health providers, local
labs, digital capture of consent data, and direct-to-patient drug distribution.
The purpose of these types of studies is to reduce or completely eliminate the
requirement of face-to-face interactions between researchers and participants”.