Design and Execution of Sustainable Decentralized Clinical Trials

Area of Science:

• Clinical Research
• Health Technology
• Regulatory Science

Background:

• Decentralized clinical trials (DCTs) leverage technology for remote patient monitoring, enhancing efficiency and patient convenience.
• DCTs offer advantages over traditional trials by capturing real-world data in patients' daily environments.
• Existing frameworks and guidance for DCTs are evolving but require further development.

Purpose of the Study:

• To conduct a gap analysis of existing frameworks and guidance for designing and executing DCTs.
• To identify areas where current guidance is insufficient for comprehensive DCT implementation.
• To highlight the need for enhanced sustainability assessments in DCT design.

Main Methods:

• A narrative review approach was employed to analyze frameworks and guidance from expert groups and regulatory agencies.
• An eight-element framework (suitability, protocol, IMP supply, investigators, safety, regulatory/ethics, data/technology, engagement) guided the gap analysis.
• The analysis focused on identifying gaps in guidance related to the design and execution of DCTs.

Main Results:

• The gap analysis revealed a need for comprehensive sustainability assessments across all DCT elements.
• Current guidance adequately addresses social sustainability and partially addresses economic sustainability.
• Significant gaps exist in guidance for environmental sustainability, including carbon footprint and disposal of materials.

Conclusions:

• DCTs represent a critical advancement in healthcare research, offering accelerated therapeutic development.
• There is an urgent need for more comprehensive guidance on assessing and ensuring the sustainability of DCTs.
• Future guidance should prioritize environmental sustainability considerations within DCT frameworks.