P218: Decentralized Clinical Trials: Regulatory Development and Current Practice
Poster Presenter
ChiaPing Liu
Senior Technical Specialist
Taiwan's Food and Drug Administration (TFDA) Taiwan
Objectives
To describe Taiwan’s regulatory development and implementation status of decentralized clinical trial elements and their impact on clinical trial conduct.
Method
A descriptive review was conducted based on Taiwan Food and Drug Administration (TFDA) guidance issued since 2023 and analysis of Investigational New Drug (IND) applications to evaluate the adoption trends of decentralized elements and the corresponding regulatory review considerations in Taiwan.
Results
The COVID-19 pandemic and rapid technological advancement accelerated the adoption of decentralized clinical trial approaches. In June 2023, TFDA issued guidance on decentralized elements in clinical trials, followed by additional guidelines on digital health technologies and computerized systems to ensure participant safety and data reliability. Since 2023, approximately 85% of IND applications in Taiwan have adopted hybrid models integrating decentralized elements such as remote visits, electronic patient-reported outcome (ePRO), electronic clinical outcome assessment (eCOA), electronic diaries, and remote monitoring.
To ensure data quality within these highly adopted models, these guidelines highlight the importance of adhering to the ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available when needed, and Traceable) for all electronic data. To maintain data integrity, computerized systems are required to implement secure, computer-generated, and time-stamped audit trails, alongside validated data input checks (edit checks) to prevent entry errors. Furthermore, for remote data collection tools like digital health technologies (DHTs) and ePRO, sponsors must ensure continuous data transmission to prevent data loss and provide adequate participant training to ensure the accuracy and reliability of the captured data. Concurrently, Clinical trial sites enhanced infrastructure to support flexible recruitment and remote participation, while IRBs utilized established communication platforms to address review considerations specific to decentralized trials and improve review consistency.
Conclusion
Taiwan has rapidly advanced decentralized clinical trial implementation through proactive regulatory development and stakeholder adaptation. The high adoption rate of hybrid trial models demonstrates regulatory clarity and system readiness while maintaining data quality and participant protection. Future alignment with ICH E6(R3) is expected to further optimize Taiwan’s clinical trial environment, strengthen regulatory convergence, and enhance preparedness for emerging digital health technologies and innovative trial designs.
