This in turn requires a critical review of the procedure from statistical standpoint. There are several issues concerning the design protocol that determine the data reliability. This carcinogenesis study was discussed at the beginning of class. One purpose of the study is to establish the dose-response relationships at low exposure level. The shape of the dose-response provides a basis for setting up environmental regulatory level of a carcinogen.
Data analysis amounts to dose-response modeling of binary data.
The test is based laboratory animal models with repeated measurements of behavior changes. Data analysis involves linear or non-linear mixed effects models for continuous outcomes. These models are extensions of linear or non-linear regression models to include random effects and repeated measurements. This is a recently funded clinical trial to develop predictive tools to identify scoliotic girls whose spinal curvature would progress to a point requiring surgery. Such a tool will aid for early surgical correction for patients who would eventually need it, yet avoid surgery that may not be necessary if the patient would not progress in scoliosis.