Bringing decentralised clinical trial protocols to life

Abstract

Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and replicability in clinical trial protocols incorporating DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.

Clinical investigations for medical devices

“…15 Further more, the concept of adaptive trial design is a strategy increasingly being used to make clinical investi - gations more flexible and more efficient, 16 as well as de centrali sed trials. 17 New approaches are also being im plemented for clinical investigation endpoints: While composite end points were routinely used in the past, 12 hierarchical composite endpoints are a new category defined by various disparate endpoints that are combined and are neither equivalent in severity nor assessed on the same scale. 18 Lastly, and most importantly, as for medicinal products, patient centricity is becoming more important.…”