Modeling using baseline characteristics in a small multicenter clinical trial for Barrett's esophagus.

ABSTRACT:

Objective

Utilizing data obtained during a multicenter investigation, this paper illustrates how the use of covariates and careful modeling techniques can be useful in assessing whether a negative outcome from a small multicenter clinical trial could be due to imbalance in baseline characteristics. The Chemoprevention for Barrett's Esophagus Trial (CBET) was a phase IIb, multicenter, randomized, placebo-controlled trial of celecoxib in patients with Barrett's esophagus. The primary outcomes for the original study were the proportion of biopsy samples exhibiting dysplasia in the celecoxib and placebo groups. The secondary and tertiary outcomes included histologic change and measurements of biologically relevant markers, including COX-1 and -2 mRNA, prostanoid levels, and methylation

SUBMITTER: Shar AO 

PROVIDER: S-EPMC3779362 | biostudies-literature | 2009 Jan

REPOSITORIES: biostudies-literature