|
Activity Number:
|
495
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Thursday, August 2, 2007 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #309007 |
|
Title:
|
Longitudinal Data Analysis in Medical Device Clinical Studies
|
|
Author(s):
|
Chang S. Lao*+ and Harry F. Bushar
|
|
Companies:
|
Food and Drug Administration and Food and Drug Administration
|
|
Address:
|
1350 Piccard Drive, Rockville, MD, 20850,
|
|
Keywords:
|
Piecewise Linear spline model ; Summary statistics ; Repeated measurements ; Analysis of covariance
|
|
Abstract:
|
Several statistical approaches are discussed for analysis of longitudinal clinical data from a two independent-group, randomized, prospective, multicenter study of patients with benign prostate hyperplasia (BPH) who are treated with either a new transurethral microwave thermotherapy device (TUMT) or sham control during a 6-month follow-up study. The primary clinical endpoint, the American Urological Association (AUA) symptom score is illustrated in this paper. The primary effectiveness null hypothesis is no treatment effect at any follow-up time against the alternative hypothesis of a favorable treatment effect at one or more follow-up times. The change of baseline and longitudinal slopes were analyzed by a piecewise linear spline regression model with knot at month 1. Statistically significant lower mean AUA scores were found in the TUMT group than the sham group at months 3 and 6.
|
