|
Activity Number:
|
522
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Thursday, August 7, 2008 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #301414 |
|
Title:
|
Safety Findings in Clinical Trials: Are They Real, or Just Coincidental?
|
|
Author(s):
|
Mani Lakshminarayanan*+ and Amarjot Kaur
|
|
Companies:
|
Merck & Co., Inc. and Merck & Co., Inc.
|
|
Address:
|
, , ,
|
|
Keywords:
|
Early Phase trials ; Correlated endpoints ; Family-wise Error Rate ; False discovery rate ; Coincidence ; Adverse Events
|
|
Abstract:
|
In all phases of clinical trials, the underlying risk of an investigational drug is determined based on multiple type/number of safety endpoints including adverse events, laboratory data, vital signs, electrocardiogram and others. Due to the inherent multiplicity in safety data, inferential procedures (if employed) tend to control false positive rates using procedures based on p-values. Most of these procedures are designed to control either the family-wise error rate (FWER) or the false discovery rate (FDR). The p-plot method is useful in estimating the unknown number of true null hypotheses out of all hypotheses that are involved in the multiplicity. In this paper, we will examine the impact of small samples (Phase-II trials) as well as the correlation between safety endpoints on various measures that are outlined above. Simulated data will be used to compare the results.
|
- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
Back to the full JSM 2008 program |
