DECENTRALISED CLINICAL TRIALS IN THE EU

What is a decentralised clinical trial (DCT)?

DCTs can take a variety of forms depending on patients’ needs, study protocol, drug company preferences, or regulatory requirements. Trials may be remote and decentralised from start to finish-with no physical contact between participants and investigators—or they may rely on hybrid designs that incorporate only certain elements of decentralization.

Benefits of DCTs

• Faster and simpler patient recruitment
• Increased participant adherence and retention
• Faster speed to trial completion
• Reduction in travel-, site- and time-related budget overruns

Digital solutions for innovative, regulatory-friendly and data-savvy DCTs

Based on a breadth of experience facilitating remote studies around the world, we propose five key digital strategies to help overcome EU regulatory challenges in the utilisation of DCTs.

1. E-consent and virtual visits
2. Site-agnostic IMP delivery and tracking
3. Smart packaging
4. Digital communication platforms
5. Centralised monitoring dashboards