Principal Investigator: James Rochon, Ph.D.
n this research, we propose to address the issue of
adjusting for confounders observed post-randomization in
randomized clinical trials. Example of these confounders include
patient "compliance" measured through pill counts and other
biochemical markers, the occurrence of co-morbid events, the use
of concomitant and "rescue" medications, withdrawal from the
assigned therapy, and so on. Since the confounder is observed
following randomization, it can be considered as an outcome
measure and analyzed accordingly. Previous research has begun
from this premise and demonstrated how to adjust inferences on
the primary endpoint for the influence of these confounding
variables. In the current study, we propose to extend previously
developed methodologies in several important directions: (1)
develop a methodology to perform inference on a primary response
variable adjusting for a survival confounding measure in repeated
measures experiments; (2) develop a methodology in longitudinal
data to adjust for informative censoring and other missing value
problems; (3) perform a simulation study of the proposed
estimation and hypothesis testing procedures; (4) develop
procedures for analyzing bivariate repeated measure data; and,
(5) develop a general methodology for performing sample size
calculations for discrete and continuous repeated measures
studies. It is expected that a fully validated methodology for
adjusting for confounders arising post randomization will be
forthcoming from this research. Grant from NCI, 1-R01-CA70286-
01, 1996-1999.
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