Decentralized Clinical Trials: Opportunities and Challenges

Decentralized clinical trials hold tremendous potential to revolutionize clinical research by making it more inclusive, efficient, and patient-centric. However, realizing these benefits requires thoughtful implementation and continuous innovation. 

The industry is committed to exploring and supporting technologies that advance the future of clinical trials while upholding the highest standards of quality and integrity. Let’s take a closer look.

What Are Decentralized Clinical Trials?

Decentralized clinical trials refer to studies that utilize digital technologies to allow for remote participation, data collection, and monitoring. These trials may employ telemedicine, wearable devices, mobile apps, and home health visits to reduce or eliminate the need for in-person site visits. 

In contrast to conventional centralized trials, where participants must travel to a clinical site regularly, DCTs bring the trial to the participant, often resulting in greater convenience and wider reach.

Opportunities in DCTs

Broader Participant Access

One of the most compelling advantages of DCTs is their potential to increase accessibility. Participants who live far from research centers or have mobility issues can still enroll and contribute. This expands the demographic and geographic diversity of clinical trials, which enhances the generalizability of the data collected.

Improved Patient Retention

By reducing the burden of travel and time commitments, DCTs can help maintain participant engagement throughout the study. Higher retention rates lead to more reliable data and fewer delays in trial timelines.

Real-World Data Collection

Remote monitoring tools and wearable devices enable continuous and real-time data collection in a naturalistic setting. This "real-world" data can provide deeper insights into how a treatment performs in day-to-day life, beyond the artificial environment of a clinical site.

Cost Efficiency

While the upfront investment in technology can be significant, DCTs may ultimately reduce costs associated with site management, staffing, and participant travel reimbursements.

Challenges and Considerations

Data Security and Privacy

With large volumes of data being transmitted digitally, ensuring the security and privacy of participant information becomes a top priority. Researchers must comply with strict regulatory standards like HIPAA and GDPR while maintaining participant trust.

Technology Access and Literacy

Not all participants have access to smartphones, reliable internet, or the technical skills to navigate digital platforms. This can inadvertently exclude certain populations or introduce variability in data quality.

Regulatory Uncertainty

Although regulatory agencies like the FDA and EMA are increasingly supportive of DCTs, the guidelines continue to evolve. Researchers must stay informed and agile to remain compliant across jurisdictions.

Protocol Complexity

Designing a decentralized protocol that ensures data integrity, participant safety, and scientific validity can be more complex than traditional models. Hybrid models—combining in-person and remote elements—are often necessary to strike the right balance.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.