Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
|
|
Tweet | ||
| CE_34T | Wed, 8/6/2014, 10:00 AM - 11:45 AM | W-Alcott | |
| Designing Confirmatory Trials with Multiple Endpoints in East® 6.3 — Professional Development Computer Technology Workshop | |||
| ASA , Cytel Inc. | |||
| The recently released East 6.3 on Cytel's Architect Platform has vastly expanded simulation capabilities. We'll illustrate two important new simulation tools for designing and monitoring clinical trials. 1. Trials with Multiple Endpoints: In confirmatory trials, a positive outcome on the primary endpoint is a necessary condition to file a regulatory claim, while a positive outcome on the secondary endpoints is considered to be supportive of the claim. Regulatory agencies will not, however, permit the positive results of the secondary endpoints to be included in the product label unless a testing procedure for both primary and secondary objectives is pre-specified and ensures strong control of type-1 error. We will demonstrate how the simulation capabilities of newly released East 6.3 may be used to compute sample sizes for clinical trials with multiple endpoints. The simulations will utilize serial and parallel gatekeeping procedures to ensure strong control of type-1 error. Examples will be drawn from Alzheimer's disease and oncology. The statistical methodology will be explained. 2. Predictive Interval Plots (PIPS): PIPS are a graphical tool for monitoring clinical trials (Li, Evans, Uno, Wei; Stat. Biopharm Research, 2009). They utilizes the interim data available in the middle of a trial to repeatedly simulate the remainder of the trial. The resulting series of precision intervals (or confidence intervals) of the effect size are displayed in an intuitive graphical summary that enables a data monitoring committee to judge how large a treatment effect one is likely to see at the end of the trial. It is a useful supplement to group sequential hypothesis testing and is especially valuable for judging whether a trial should be terminated for futility. | |||
| Instructor(s): Cyrus Mehta, Cytel, Lingyun Liu, Cytel | |||
2014 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Professional Development program, please contact the Education Department.
The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Copyright © American Statistical Association.