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Home / News & Events / Sequential Clinical Trial Design with Survival Endpoints Part 2

Sequential Clinical Trial Design with Survival Endpoints
Part 2: Monitoring, Reporting and Flexible Accrual, Time-to-event, and Dropout

Presented: Wednesday, June 6, 2007

Speakers: Dr. Daniel Gillen, University of California at Irvine & Dr. Michael O'Connell, Insightful Corporation

View the on-demand web cast. Download instructions on how to view the web cast.

Download the presentation file.

Download the HodskinsScrip1.q file.

Time-to-event or survival endpoints are common in clinical trials and increasingly, clinical trials are conducted using group sequential methods in order to address the ethical and efficiency issues that arise when performing experiments with human volunteers. The design, conduct, and analysis of sequential clinical trials are necessarily more involved than that for a clinical trial in which the data would only be analyzed at the end of the study.

In this Web cast we describe the additional issues that must be considered when conducting a group sequential survival trial where interest lies in comparing the hazard ratio between randomized groups. The group sequential methods are illustrated via case studies using S+SeqTrial, an S-PLUS module for the design, monitoring, and analysis of clinical trials.  In particular, we will address:

  • Group sequential design
  • Translating event rates and accrual distributions to calendar time for monitoring of trial results
  • Adjustment of point and interval estimates following group sequential testing.

Dr. Daniel GillenDr. Daniel Gillen, University of California at Irvine

Daniel Gillen received his Ph.D. in Biostatistics from the University of Washington and is currently an Assistant Professor of Statistics at University of California at Irvine.  Dr. Gillen is an active researcher in the design, monitoring and analysis of group sequential trials. A major focus of his research has been on the development of group sequential methods for longitudinal and survival trials with potentially time-varying covariate effects. He serves on a number of government and industry sponsored advisory boards related to the design and monitoring of clinical trials.

Dr. Michael O'Connell
Michael O'Connell,
Insightful Corporation

 Michael O'Connell has been working in the medical device, diagnostics, pharmaceutical and biotech arena for the past 15 years. Dr. O'Connell's background and graduate work was in applied statistics and he has published more than 40 papers on statistical methods and life science applications including calibration, mixed models, and nonparametric regression. He has also written several statistical software packages and libraries using S-PLUS, R and SAS. Most recently he has been active in bioinformatics and the statistical analysis of microarray data; and in the development of tools for analysis and reporting of clinical and safety data from S-PLUS.

Dr. O'Connell holds a Bachelors degree in Science from the University of Sydney, a Masters degree in Statistics from the University of New South Wales and a Ph.D. in Statistics from North Carolina State University.