|
Title
|
Room
|
|
Design, Monitoring, and Analysis of Group Sequential Clinical Trials
|
M-International Salon F
|
|
Date / Time
|
Sponsor
|
Type
|
|
08/06/2001
9:00 AM
-
5:00 PM
|
ASA, Biometrics Section*
|
Other
|
|
Organizer:
|
n/a
|
|
Chair:
|
n/a
|
|
Discussant:
|
|
|
CE Presenter
|
Scott Emerson
Scott Emerson
|
Description
Increasingly, clinical trails are conducted using group sequential methods in order to address the ethical and efficiency issues that arise from performing experiments with human volunteers. The design, conduct, and analysis of a sequential clinical trial is necessary more involved than that for a clinical trial in which data would only be analyzed at the end of the study. In this one day short course, additional issues that must be considered when designing, monitoring, and reporting the results of a group sequential trial will be presented.
The first half will be a qualitative presentation of issues that arise in the conduct of clinical trials, especially as it pertains to the monitoring of such trials. The intended audience is researchers who want to understand the basic principles that should be used to assess whether the monitoring plan for a particular clinical trial is appropriate. No knowledge of statistics is presumed.
The second half will be more quantitative presentation of the statistical design of clinical trials. The intended audience is researchers active in designing clinical trials or evaluating the statistical operating characteristics of such designs. Knowledge of hypothesis testing and clinical trial design for comparing means or binomial proportions in nonsequential studies is presumed.
|
|
