Decentralized Clinical Trials (DCT) are an innovative clinical trial model that uses digital technologies and remote tools. By integrating teleconsultations, wearable devices, electronic informed consent (eConsent), e-questionnaires, mobile medical units, home medication delivery, at-home testing, and remote monitoring, DCT enables participants to join studies from home or nearby locations. This model enhances recruitment efficiency, improves patient adherence, and supports real-time data collection. With a patient-centric design, DCT reduces the need for site visits, minimizes the burden on participants, and aligns with global trends in clinical research innovation.
Common Models of DCT
1.Hybrid Trials
Hybrid trials combine traditional trial procedures with digital and remote tools. Some activities take place on-site at the trial center, while others—such as virtual interviews, online reporting, or wearable device monitoring—are conducted remotely to balance efficiency and patient experience.
2.Fully Decentralized Trials
Participants are not required to visit the trial site in person. All processes—including eConsent, remote video consultations and data collection, direct-to-home medication delivery, and remote medication monitoring—are conducted virtually, enabling true at-home participation.
3.Virtual Site Support Platforms
These platforms integrate virtual site technology to manage patient interactions, collect data, and provide medical support services remotely, offering site-level trial capabilities that enhance the scalability of multi-regional trials.
Core Pillars of DCT
1.Broader Participant Reach
Digital technologies and telehealth models overcome geographic barriers, significantly improving participant diversity and trial representativeness.
2.Expanded Indication Coverage
DCT enables the inclusion of underrepresented groups such as patients with rare diseases, those with limited mobility, or bedridden individuals—promoting equitable access to clinical trials and advancing precision medicine.
3.Improved Healthcare Quality
Digital tools such as remote monitoring and mobile health devices enhance the precision and timeliness of medical services, ultimately improving the overall quality of care.
4.Increased Operational Efficiency
Decentralized processes reduce participant travel and on-site workload, streamlining trial operations and improving cost and timeline efficiency.
DCT Management Framework
1.Teleconsultation
Utilize video conferencing tools for patient interviews and clinical assessments, reducing the burden of on-site visits and improving both enrollment and compliance rates.
2.Remote Monitoring
Digital platforms allow for real-time monitoring of participant status and study progress, enhancing data quality and reducing the frequency of on-site audits.
3.Regulatory Compliance
Ensure that all trial activities comply with local and international regulations, including data protection (e.g., GDPR/HIPAA) and electronic record standards (e.g., 21 CFR Part 11), to protect participant rights and data integrity.
4.Digital Infrastructure
Build a comprehensive digital ecosystem—including tools like eConsent, ePRO, wearable devices, and remote monitoring systems—to enable real-time data collection and automate trial processes.
