What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

Decentralized clinical trials (DCTs) are an innovative approach to conducting clinical research, where some or all trial-related activities occur at locations other than traditional clinical trial sites. These locations can include participants’ homes, local healthcare facilities, or nearby laboratories.

Key Features of DCTs:

• Remote Participation: Participants can engage in the trial from their homes or local clinics, reducing the need for travel.
• Digital Health Technologies: Use of devices like activity trackers, glucose monitors, and mobile apps to collect data remotely.
• Telehealth Visits: Virtual consultations with trial personnel, enhancing convenience and accessibility.
• Increased Data Collection: Continuous or frequent data collection during participants’ routine activities, providing real-life insights into treatment effectiveness and safety².

Benefits of DCT:

• Enhanced Convenience: Easier for participants to join and stay in trials without the burden of travel.
• Broader Reach: Ability to include participants from diverse geographic locations.
• Cost Efficiency: Potentially lower costs by reducing the need for physical infrastructure and travel expenses².

DCTs are gaining momentum, especially after the COVID-19 pandemic highlighted the need for flexible and remote healthcare solutions. They represent a significant shift towards more patient-centric and efficient clinical research.

Example of a successful decentralized clinical trial

One notable example of a successful decentralized clinical trial is the ACTIV-6 trial, which was conducted to test outpatient treatments for COVID-19. This trial was part of the National Center for Advancing Translational Sciences (NCATS) program and utilized decentralized methods to reach a broader participant base.

The ACTIV-6 trial leveraged digital technologies and community partnerships to conduct the study beyond traditional clinical sites. This approach allowed for more efficient and inclusive participant recruitment, especially from underrepresented communities. 

The trial demonstrated that decentralized clinical trials (DCTs) could be more efficient, effective, and equitable, bringing treatments to a wider population more quickly.

Lets discuss few more examples of successful decentralized clinical trials (DCTs):

1. The REMOTE Trial: This was one of the first fully decentralized trials conducted by Pfizer. It aimed to evaluate the efficacy and safety of a drug for overactive bladder. The trial utilized digital tools for patient recruitment, consent, and data collection, significantly reducing the need for physical site visits.
2. The CHIEF-HF Trial: Conducted by Bristol Myers Squibb, this trial focused on heart failure patients. It used a decentralized approach to monitor patients remotely through wearable devices and mobile apps, allowing for continuous data collection and improved patient engagement.
3. The VERKKO Study: This study, conducted by Sanofi, aimed to evaluate a new diabetes treatment. It was notable for its use of telemedicine and home health visits, which enabled participation from a diverse patient population across different geographic locations³.

These examples highlight the potential of DCTs to enhance patient recruitment, improve data quality, and make clinical trials more accessible and efficient.

What are the challenges of implementing DCTs?

Implementing decentralized clinical trials (DCTs) comes with several challenges:

1. Technology Barriers:
   • Access and Literacy: Not all participants have access to the necessary technology or the digital literacy to use it effectively.
   • Data Security: Ensuring the security and privacy of patient data collected remotely is crucial and can be complex.
2. Regulatory and Compliance Issues:
   • Regulatory Variability: Different regions have varying regulations, making it challenging to standardize DCTs globally.
   • Compliance: Ensuring that all aspects of the trial comply with regulatory requirements can be more difficult when activities are decentralized.
3. Data Management:
   • Data Integration: Combining data from various sources and ensuring its accuracy and consistency can be challenging.
4. Participant Engagement:
   • Retention: Keeping participants engaged and motivated throughout the trial can be harder without face-to-face interactions.
   • Support: Providing adequate support to participants remotely, especially for those with complex needs, can be difficult.
5. Operational Challenges:
   • Logistics: Coordinating the delivery of trial materials and medications to participants’ homes can be logistically complex.
   • Training: Ensuring that both participants and local healthcare providers are adequately trained to perform trial-related activities.Despite these challenges, the benefits of DCTs, such as increased accessibility and convenience, make them a promising approach for the future of clinical research. Continuous advancements in technology and regulatory frameworks are helping to address these challenges.

1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements
2. https://www.fda.gov/drugs/cder-conversations/evolving-role-decentralized-clinical-trials-and-digital-health-technologies
3. https://ncats.nih.gov/news-events/news/ncats-report-highlights-decentralized-clinical-trials-challenges-opportunities
4. https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis