Speaker: Tai Xie, Ph.D.
CEO, Brightech Intl & CIMS Global

Abstract: Modern clinical trials need to be designed with much flexibility and efficiency.  Flexibility includes adaptation based on new information while trial is ongoing and being monitored dynamically with cumulative data.  Efficiency includes adequate study power and timely decision making regarding the future course of the trial.  Both aspects require the protection of trial integrity and validity.  Adaptive sequential designs have been proposed for clinical trials for the last decades. However, traditional computing environment could not accommodate trial monitoring at any time in a timely fashion.  In this high-speed, AI- (artificial intelligence)-everywhere era, we introduce Dynamic Data Monitoring concept in which the cumulative data are monitored continuously, and the treatment effect is examined timely over the trial duration.  Changing frequency and schedules of the interim analyses can be monitored at real time.  The accumulating data can be viewed whenever new data is available and the timing of efficacy and futility assessments and sample size adaptation is made very flexibly, and the type I error rate is always controlled.  Numerical and real study examples and simulations are presented. (Collaborated with Drs. Gordon Lan, Joe Shih, and Peng Zhang)

Bio3 Seminar Series sponsored by 
Department of Biostatistics, Bioinformatics & Biomathematics (DBBB)

Thursday, November 14, 2019 at 1:00pm to 2:00pm

Pre-Clinical Science Building, LA4
3900 Reservoir Road, N.W., Washington

Event Type

Academic Events


Students, Faculty/Staff


Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Biomedical Graduate Education, Biostatistics Graduate Program



Tai Xie, Ph.D.

Event Contact Name

Veronica Chiu

Event Contact Email

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