Abstract #301037

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JSM 2003 Abstract #301037
Activity Number: 336
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #301037
Title: Imputing Interactions Between Treatment and an Unmeasured Covariate in Clinical Trials
Author(s): Barry R. Davis*+ and Charles Erwin Ford and Lei Lei
Companies: University of Texas and University of Texas and Texas Tech University
Address: 1200 Herman Pressler St., Houston, TX, 77030-3900,
Keywords: clinical trial ; treatment-covariate interaction ; imputation
Abstract:

Interest in the interaction between a treatment intervention and an unmeasured binary covariate often develops during an ongoing clinical trial or after its completion. This can happen when new information from an outside source suggests such an interaction or when a new measurement, such a genotype, is discovered. In addition, measurements of known covariates may have been prohibited due to economical or informed consent issues. Such interaction, however, can be imputed if estimates of the following are available: (1) the prevalence of the covariate; (2) the odds ratio of the covariate and disease in either treatment arm of the trial, and (3) the incidence of disease in both treatment arms. In the context of a clinical trial, the covariate and the treatment are independent due to randomization. Case-only analyses can be used to evaluate such interactions. Examples from completed hypertension trials will be used to illustrate this method.

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