Denmark Outlines Vision For Decentralized Trials Beyond COVID-19
The Danish medicines regulator has set out its expectations on key elements of decentralized clinical trials as part of Denmark’s ongoing effort to develop a robust regulatory framework in this area.
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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.
Trial sponsors are proactively seeking opportunities to incorporate decentralized elements into their studies, but the lack of regulatory guidance makes it a difficult exercise.
The COVID-19 pandemic has given a new impetus to Sweden’s ongoing efforts to support decentralized clinical trials.