JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2009 Program page

Activity Number: 377
Type: Contributed
Date/Time: Tuesday, August 4, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303410
Title: Primary Efficacy Endpoint in Clinical Trials of Antiepileptic Drugs: Change or Percent Change
Author(s): Ohidul Siddiqui*+
Companies: FDA
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20993,
Keywords: AED trials ; parametric tests ; Non-parametric tests ; change from baseline
Abstract:

In randomized clinical trials of antiepileptic drugs (AEDs), the seizure frequency per x-days during baseline and treatment phase periods are recorded to evaluate efficacy of a drug. The seizure frequency data are often non-normal, and hence an appropriate mathematical transformation is necessary for a statistical analysis. The most common transformations are either to take log transformation of the data, or to calculate percentage change (PC) from baseline. The log-transformed post baseline seizure frequency data is analyzed using a parametric ANCOVA model. The PC data are analyzed using either Wilcoxon rank-sum test on the PCs, or ANOVA / ANCOVA analysis on the ranks of PCs. In this research, an attempt is made to evaluate an impact of choosing a particular transformation on seizure frequency data of AED trials.

  • 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 2009 program


JSM 2009 For information, contact jsm@amstat.org or phone (888) 231-3473. If you have questions about the Continuing Education program, please contact the Education Department.
Revised September, 2008