Version 1.0 - February 2023

Decentralized Clinical Trials

Decentralized Clinical Trials (DCT) in the context of drug development is a rapidly evolving field. The driving force behind this development is the fundamental idea of increasing the diversity of trial participants both geographically and demographically. Additionally, there is the potential for collecting data with higher temporal resolution, closer monitoring of side effects, and reducing the overall cost of the study. This is achieved, among other things, by reducing the need for visits to the trial clinic and instead performing a number of trial activities in the participant's own home, which can minimize the overall inconvenience of participating in a clinical trial.

Decentralized elements in clinical trials can take many different forms and are expected to be particularly used in so-called hybrid trials, where specific parts of the trial are conducted in places other than the trial clinic. This includes monitoring physiological parameters, answering questionnaires, and blood sampling performed by qualified healthcare personnel.

The ethics of decentralized clinical trials is a relatively unexplored area, and therefore the MREC (Medicinal Research Ethics Committees) has taken the initiative to create ethical guidance within this topic. In addition, as of January 31, 2022, a pilot scheme on the use of decentralized consent processes in clinical trials will be initiated.

Last updated 01-02-2024

Please note that the text on this page has been translated with the help of AI. If you find any errors in the text or something is unclear, please contact us for clarification.

Et netværk af prikker