Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges

Area of Science:

• Clinical Research
• Pharmaceutical Sciences
• Health Informatics

Background:

• Decentralised clinical trials (DCTs), also known as virtual or remote trials, aim to improve patient accessibility.
• Traditional clinical trials often require significant patient travel, leading to high dropout rates and delays.
• The COVID-19 pandemic accelerated the adoption and regulatory acceptance of DCTs.

Purpose of the Study:

• To highlight the benefits of DCTs in enhancing patient centricity and trial efficiency.
• To discuss the role of digital technologies in facilitating remote data collection and patient engagement.
• To underscore the growing importance of DCTs in modern drug development.

Main Methods:

• DCTs utilize a range of digital technologies for remote data collection and participant engagement.
• The approach involves minimizing or eliminating the need for patients to travel to trial sites.
• Hybrid models combining remote and in-person procedures are employed.

Main Results:

• DCTs have demonstrated reduced participant dropout rates and increased study effectiveness.
• The patient-centric model improves convenience and engagement, leading to better real-world data.
• Faster drug development timelines and significant cost savings for sponsors are achieved.

Conclusions:

• Decentralised and patient-centric approaches are integral to the future of clinical trial conduct.
• Regulatory bodies like the USFDA and EMA are updating guidelines to support DCTs.
• Pharmaceutical companies should adopt DCTs to streamline drug development and prioritize patient needs.