Bringing clinical trials home: European regulatory perspectives on decentralized clinical trial approaches

Abstract

Clinical trials evaluate the effects of medicines in people. Decentralized clinical trial (DCT) approaches aim to bring clinical trial activities closer to participants’ homes, for example by using wearables and apps to collect data. This thesis aims to identify opportunities and challenges for DCT approaches in Europe and to evaluate the current use of DCT approaches.

In this thesis, we report that DCT approaches were permitted and supported by guidance from health authorities during the COVID-19 pandemic. Through interviews, various actors involved in assessment of clinical studies and medicines reported that DCT approaches have the potential to reduce the burden for participants and to increase the applicability of trial results because data is collected in settings that better reflect the real world. On the other hand, it was mentioned that participants may experience more difficulty because of limited ability to use digital devices or more responsibilities related to obtaining study measurements.

We found that DCT approaches are used to a limited extent and mostly complementary to site-based approaches. In a study that compared characteristics of participants from a DCT and participants from a clinical trial conducted in a clincial site to patients in daily practice, we concluded that participants in the DCT looked more like patients in daily practice in terms of age, lifestyle factors, and therapy use but not in terms of sex.

Although the use of DCT approaches is currently limited, explorative research can help to further understand the benefits and should therefore be facilitated.