Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment

Area of Science:

• Clinical research methodology
• Health informatics
• Systems science

Background:

• Growing interest in decentralized clinical trials (DCTs) to address challenges in clinical development.
• Existing issues include participant burden, access, and data management complexities.
• DCTs offer potential solutions for improving efficiency and inclusivity in research.

Purpose of the Study:

• To examine the integration and impact of DCT solutions on clinical trial processes.
• To propose a framework for evaluating DCTs using systems thinking.
• To identify enablers for overcoming DCT implementation challenges.

Main Methods:

• Conceptual framework development using systems thinking.
• Iterative assessment of stakeholder pain points related to DCTs.
• Analysis of DCT deployments and their integration into existing systems.

Main Results:

• DCTs can mitigate participant burden and enhance data quality.
• Customization of DCTs to patient needs and trial requirements is essential.
• DCT elements introduce new demands on existing clinical trial systems.

Conclusions:

• Decentralized clinical trials require tailored approaches for optimal patient engagement and trial success.
• Further research is needed to empirically quantify the impact of DCTs.
• DCTs hold promise for making clinical research more accessible and relevant to diverse populations.