Advancing Innovative Clinical Trial Design
As part of Cytel’s webinar series on “Advancing Innovation in Clinical Trial Design”, we have seen how the drug development process has been optimized in recent years. The traditional clinical trial model has faced significant challenges due to increased competition. In the past 2 years, the outbreak of COVID-19 also imposed a disruptive impact onto the sustainability of the clinical research ecosystem that steers pioneer efforts in advancing digital trials. The digital trial leverages the digital applications and solutions (such as real world data analytics, insights, sensors, apps) to improve clinical design from start-up to closure, reduce screening failures with digital feasibility and screening, improve participant access and engagement with virtual communication tools, enhance operation quality and efficiency with reduced site visits via remote monitoring, and streamline data collection process with e-Source. The integrated digital solutions also enable the decentralized trial operation model to successfully harness digital methods and the myriad benefits of such technologies for clinical research.
During this webinar Luyan Dai will share the recent development of the digital applications and pilot implementation in China.
Luyan Dai, Ph.D., is the Vice President of Strategy and Innovation, and Chief Statistician at Happy Life Tech. She has more than 14 years experiences in pharmaceutical industry with globally operated multinational pharmaceutical and biotech companies taking responsibilities of compound development, organization development and team leadership. She was the former head of medicine strategy and clinical research at Harbour Biomed, being responsible of clinical research team development and portfolio product development from strategy to operation covering therapeutic areas of ophthalmology, oncology, neurology and immunology. Before joining Harbour Biomed, she was the regional head of Statistics, Asia at Boehringer Ingelheim, taking responsibilities of strategic initiative steering, organizational development and operational oversight of Asia statistical team contributing to local, regional and global projects across therapeutic areas.
Luyan has more than 20 SCI publications and book chapter authorships. She is an expert in multi-regional clinical trial, application of RWE/RWD in regulatory strategy, innovative study design and Bayesian application in drug development and lifecycle maintenance and optimization. Moreover, she is a directional leader of decentralized clinical trial and digital health technologies in China industry; Member of DIA China Advisory Council. Luyan has a Ph.D. in Statistics at University of Missouri-Columbia and Bachelor of Science in Statistics at Fudan University.