A recent study published in Frontiers in Public Health highlights the benefits of decentralized clinical trials (DCTs) in terms of participant experience and environmental impact. The study, a double-blind randomized controlled trial conducted in Singapore (PROMOTE Study), compared a fully decentralized model with a traditional in-person study.
The decentralized study achieved a 97% participant retention rate and high completion rates for clinical data, including biological samples. Qualitative interviews revealed that participants found the DCT model convenient and safe, especially during the COVID-19 pandemic. This suggests that DCTs can improve patient engagement and reduce barriers to participation.
Environmental Benefits of DCTs
The study also assessed the environmental impact of DCTs using life cycle assessment. The results indicated that the decentralized model is more environmentally friendly and less detrimental to human health compared to traditional trials. This is primarily due to the reduction in participants' use of cars for site visits.
Considerations for Implementing DCTs
The researchers emphasize the importance of careful planning when implementing DCTs, particularly regarding data flow, database structure, and data protection measures. While the study focused on environmental impact, it acknowledges that participant safety, convenience, and data quality are also crucial factors to consider when evaluating the suitability of a DCT approach.
Conclusion
The study concludes that decentralized and hybrid clinical trials offer efficiency, effectiveness, and environmental benefits. The authors encourage further research and adoption of these approaches to improve the sustainability of clinical trials. Environmental sustainability should be among the factors that are evaluated when selecting trial models.