Are Trial Sponsors Treading On Investigators’ Toes In Decentralized Trials?

The Danish regulator’s experience with reviewing and inspecting decentralized elements in clinical trials highlights concerns around the blurring of lines that divide the roles and responsibilities of sponsors and trial investigators.

Woman discussing with doctor through tablet PC at home
Decentralized Trials Have Grown In Popularity Since The COVID-19 Pandemic • Source: Alamy

A year after the Danish Medicines Agency became one of the first EU regulators to issue national guidance on supporting decentralized trials (DCTs), it has developed good insight into the types of challenges that companies typically face in designing and executing such studies.

A common problem with such trials is the “blurring” of the traditional division of roles between sponsors and trial investigators,...

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