Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THIS TOPIC?  Decentralized clinical trials (DCTs) have the possibility to improve clinical trial conduct. However, regulatory requirements and perceived low degree of regulatory acceptance may impact the implementation of DCTs. WHAT QUESTION DID THIS STUDY ADDRESS?  What are the opportunities and challenges for the authorization and implementation of DCTs in Europe from a regulators' perspective? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?  Regulators expect that DCTs will facilitate the recruitment of underserved patients. Data collected in DCTs are furthermore expected to be more representative of the realworld. However, concerns regarding investigator oversight and safety monitoring may challenge DCT implementation. Regulators suggested that further experience with DCTs can be exerted through hybrid clinical trials, combining decentralized and on-site activities. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE? This research helps progress the implementation of DCTs by providing insights into the opportunities and challenges for its implementation from a European regulator's perspective. The themes described in this research should be considered when designing a DCT and could help to educate regulators on DCTs.

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