Publication:

Decentralized clinical trials-balancing promise and pitfalls in modern research: a systematic review

Background Traditional clinical trials often face limitations in participant diversity and accessibility due to geographic and logistical constraints. Decentralized clinical trials (DCTs) have emerged as a potential solution to address these challenges by leveraging digital and remote technologies. Despite their advantages, there remains a lack of comprehensive understanding regarding the opportunities and challenges associated with DCTs. This systematic review explores the opportunities and challenges of DCTs, providing insights into their implementation and impact on clinical research. The review analyses DCTs' effects on trial conduct and outcomes, offering recommendations for future design and execution.

Methods A systematic literature review was conducted following PRISMA guidelines, searching major databases for studies published between 2018 and March 2024. The review analyzed 18 peer-reviewed articles, assessing risk of bias using an adapted Cochrane tool.

Results The results highlighted that DCTs enhance participant engagement, improve accessibility and increase participant diversity, offering potential cost savings and improved trial efficiency. However, challenges such as ensuring data integrity, overcoming technological barriers and addressing regulatory compliance were also noted. The majority of the included studies demonstrated a low risk of bias across all domains, enhancing the reliability of these findings.

Conclusions This review underscores DCTs' potential to transform clinical research by improving efficiency, accessibility and participant diversity. Successful implementation requires addressing technological, ethical and regulatory challenges. Future research should focus on standardized best practices, equity issues and comparative studies with traditional trials. These findings have significant implications for shaping future clinical trials.