# Adaptive Design Theory and Implementation Using SAS and R by Mark Chang

By Mark Chang

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Extra info for Adaptive Design Theory and Implementation Using SAS and R (Chapman & Hall Crc Biostatistics)

Sample text

One is the goal of an adaptive/‡exible design to allow some type of mid-study changes that are prospectively planned in order to maximize the chance of success of the trial while properly preserving the type-I error rate because some planning parameters are imprecisely known. Another goal is to enrich trials with subgroups of patients having genomic pro…les likely to respond or less likely to experience toxicity (Hung, O’Neill, Wang, and Lawrence, 2006). "Adaptive designs should be encouraged for Phases I and II trials for better exploration of drug e¤ects, whether bene…cial or harmful, so that such information can be more optimally used in latter stages of drug development.

1 Arteriosclerotic Vascular Disease Trial Cholesterol is the main lipid associated with arteriosclerotic vascular disease. The purpose of cholesterol testing is to identify patients at risk for arteriosclerotic heart disease. The liver metabolizes cholesterol to its free form and transports it to the bloodstream via lipoproteins. ”Therefore, cholesterol is the main component of LDLs and only a minimal component of HDLs and very low density lipoproteins. LDL is the substance most directly associated with increased risk of coronary heart disease (CHD).

The SAS variables are de…ned as follows: sWithin = Within-subject standard deviation on log-scale; uRatio = ratio of two treatment means; n = total sample-size; and power = power of the test. 3 Population and Individual Bioequivalence An FDA 2001 guidance describes two new approaches, termed population bioequivalence and individual bioequivalence (PBE, IBE). PBE is concerned with assessing if a patient who has not yet been treated with R or T can be prescribed either formulation. IBE is a criterion for deciding if a patient who is currently being treated with R can be switched to T.