Decentralized Clinical Trials (DCT) is 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.
Pathway to DCT in Taiwan
The 2025 symposium centers on the theme “Pathway to DCT in Taiwan — Building a Decentralized Clinical Trial Ecosystem.” Decentralized Clinical Trials (DCT) emphasize a patient-centered model, utilizing telemedicine, wearable devices, electronic consent, mobile health units, and digital monitoring platforms. This approach enables participants to take part in trials from home or nearby locations, thereby reducing participation burdens while enhancing recruitment efficiency, patient compliance, and the timeliness and integrity of data collection.
This symposium marks not just a single event, but the beginning of Taiwan’s journey toward the future of decentralized clinical trials. Through sustained annual gatherings, we will collectively witness the forward-looking strategies across the clinical research sector and its profound contributions to global healthcare innovation.
Common Models of DCT
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.
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.
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
Digital technologies and telehealth models overcome geographic barriers, significantly improving participant diversity and trial representativeness.
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.
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.
Decentralized processes reduce participant travel and on-site workload, streamlining trial operations and improving cost and timeline efficiency.
DCT Management Framework
Utilize video conferencing tools for patient interviews and clinical assessments, reducing the burden of on-site visits and improving both enrollment and compliance rates.
Digital platforms allow for real-time monitoring of participant status and study progress, enhancing data quality and reducing the frequency of on-site audits.
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.
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.