DIA EUROPE 2021

Innovative technologies and approaches can be used in clinical trials to bring trials closer to patients. There are many benefits to this approach, from increased patient recruitment and retention to the subject population being more representative and less homogeneous. Digital technologies can be used to conduct patient visits at home, Informed Consent can be obtained virtually and patient performance can be measured through sensors. Approaches such as mobile nursing or the use of local practitioners and local labs can facilitate the treatment of patients and avoid long travels to the study site. These approaches can be combined in different ways to conduct trials fully decentralised, with no patient physical visits to the study site, or hybrid trials that use a mix of on-site visits and remote visits. Not all clinical trials, all Investigational Medicinal Products and all patient populations are amenable to fully decentralised trials. From a regulatory perspective, local regulations oversee many of the aspects of decentralised clinical trials, such as the possibility to ship IMP directly to the patient, the acceptability the acceptability of the data collected remotely, eConsent, and to use local laboratories and HCPs as well as the contracting and training needs for these. The patient perspective is a key consideration for the design of successful decentralised trials. Some patients will see benefits in remote telemedicine visits, while others may cherish the on-site visit and the in-person discussions with the study team. This is why partnering with patients and patient advocacy groups is essential before the design of a decentralised clinical trial.