In traditional centralized trials, participants typically attend face-to-face appointments at specific healthcare facilities, known as sites, where data is collected. This method ensures controlled conditions for consistent data collection and maintains research integrity. However, while it improves data quality, it may limit participation and diversity within the study, potentially excluding certain demographic groups. The requirement for participants to travel to these sites for follow-up visits can also be inconvenient, affecting their willingness to remain in the clinical trial.
The FDA defines decentralized clinical trials (DCTs) as studies conducted using telemedicine and mobile healthcare technologies, known as digital health technologies (DHTs). These trials allow participants to stay at home for most or all of the study, using advanced online communication tools and devices like portable activity trackers, blood pressure monitors and various wearable, ingestible, or implantable sensory devices. By eliminating the need for physical presence, DCTs break down geographic barriers, enabling more population to participate and providing more data than traditional trials. This approach enhances participant engagement and retention through remote monitoring and lowers costs associated with site management, workloads, and travel. However, with the increased data collection from various technologies, there may be challenges with data integrity, as the quality can vary. Additionally, the extensive data requires robust backup systems. While all trials have some data security risks, DCTs face greater challenges in protecting sensitive health information.
A major player in the industry; ICON, surveyed nearly 4,000 patients from North America, Europe, and Japan. The findings showed that 26% of respondents preferred to conduct study procedures on-site. Most participants either favoured a hybrid approach that combines remote and on-site visits or had no particular preference, highlighting the need for flexible options. While digital devices, mobile applications, and online communication are helpful, they cannot fully replace in-person interactions. Therefore, the industry must find the right mix of virtual and on-site care.
Decentralized Clinical Trials (DCTs) have their own set of challenges and are not in any way simpler than traditional studies. Similar to traditional trials, participant recruitment necessitates a comprehensive strategy, and synchronizing incoming data is particularly challenging. It is important to consider the study type, the target population, and available resources when deciding whether to use centralized or decentralized trials. The best course of action going forward is most likely a hybrid strategy that incorporates wearables and mobile health applications to capitalize on the advantages of both models. Better ways to integrate DHTs with other electronic systems are anticipated as technology advances. As technology advances, better methods of integrating DHTs with other electronic systems should become possible. These developments should make data collection and analysis easier, which is important for patient-centred clinical trials, and should lead to better trial outcomes overall when virtual trial models are used.
References
- Borfitz , D. (2024, March 5). Future looks bright for decentralized clinical trials. Pubs – Clinical Research News Online. https://www.clinicalresearchnewsonline.com/news/2024/03/05/future-looks-bright-for-decentralized-clinical-trials
- Medidata. (2024). Decentralized clinical trials – key trends and statistics. Medidata Solutions. https://www.medidata.com/en/decentralized-clinical-trials-key-trends-and-statistics/
- Nolan, C. (2023, December 12). Decentralized Clinical Trials in 2024: a Look Ahead. Crucial Data Solutions. https://crucialdatasolutions.com/blog/decentralized-clinical-trials-in-2024-a-look-ahead/
- Smith, D. S., & Hunter, S. J. (2024, January 4). Clinical Trial Trends & Insights 2024. WCG. https://www.wcgclinical.com/insights/clinical-research-trends-insights-2024/
Apryl Devoe
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