Decentralized clinical trials cover a multitude of elements that reduce, or in some cases even eliminate, the need for the trial participants to go to the clinical trial sites.
On 10th September 2021 announced the release of the updated guidance on the implementation of decentralized elements in clinical trials with medicinal products
Danish Medicines Agency has launched a project with the aim of ensuring a contemporary and robust regulatory framework for the decentralization of clinical trials. The main focus is that DCT elements are not implemented at the expense of the rights and safety of trial participants, the data integrity, nor increase the burden on the investigator sites.
The purpose of this document is to provide guidance on the implementation of decentralized elements in clinical trials with medicinal products and to highlight challenges.
This guidance reflects upon the challenges raised in clinical trial applications, scientific advice, our dialogue forum on decentralized clinical trials, other inquiries as well as challenges emerging in the ongoing collaboration with national, European, and international partners.