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Assessing heterogeneity in clinical trials using the frailty model (Paperback)
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Assessing heterogeneity in clinical trials using the frailty model (Paperback)
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While the primary objective of multicenter clinical trials is to
compare treatments for a specific disease, they also contain a lot
of relevant additional information. For example, it may be
interesting to investigate heterogeneity in outcome and in
treatment effect over centers. Considering a frailty model
including a random center effect and a random treatment by center
interaction term, we demonstrate how to quantify this
heterogeneity, to interpret it based on medically relevant
quantities, and to identify center and patient specific factors
explaining it. Based on the same idea, we also propose to study
heterogeneity in prognostic index effect over centers, and to use
this information to get a new insight in the validation of
prognostic indices. Various approaches are discussed to fit such a
frailty model, and a Bayesian approach based on the Laplace
approximation is detailled. We illustrate this research using data
from an EORTC multicenter clinical trial for breast cancer and from
a pooled database of seven EORTC clinical trials in bladder cancer
patients.
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