Decentralised Clinical Trials (DCT)

Chair: Dr. Angela D’Errico

Co-Chair: Dr. Antoinette van Dijk

Mission statement:
Sharing of case studies with related resolution of issues and objections encountered by both regulatory authority and ethics committees.

Objectives:
To have a clear view of the different degrees of decentralisation that have been applied so far in clinical trials, both interventional and observational, approved in Italy and consequent acceptability from the regulatory point of view.
To share the privacy and confidentiality aspect and the EC’s approach to active but especially passive data collection, particularly when the biological, behavioural and social information collected by digital devices is not related to the primary objectives of research.

Expected Outcomes:
– To have a clearer picture with respect to what is currently going on as DCTs in Italy.
– To promote the use of DCTs to speed up and make clinical trials cheaper, while perfectly maintaining all the characteristics of patient safety and scientific validity.
– Launch a discussion also on what is indicated in the National Recovery and Resilience Plan (PNNR) where it is clearly stated that digitisation and innovation, together with ecological transition and social inclusion, represent strategic axes around which the plan itself is developed. In addition, it also contains the following statements, related to the health reality: “realise safe, technological, digital and sustainable hospitals”; “overcome the limited diffusion of telemedicine tools and activities”.