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Unformatted text preview: Basic Data Analysis for Comparative Clinical Trials This discussion will focus on the standard comparative clinical trial (typically a randomized Phase III study). I will start with an example from the recent medical literature: the Womens Health Initiative Study, looking first at the component focused on calcium plus vitamin D, then at the combined hormone therapy group. The study was very complicated. It has both a clinical trial component and an observational component. The central part is a RCT to evaluate health benefits and risks of four distinct interventions: Dietary modification (reduce total fat and saturated fat, increase vegetables, fruit and grains) (DM) Hormone replacement with estrogen alone (HT-E) Hormone replacement with estrogen plus progestin (HT-EP) Calcium plus vitamin D (CVD). The study design for the RCT was a partial factorial design. Sample size 68,132 post-menopausal women aged 50-79. Women were stratified into those with and without uterus (because HT-E not suitable for those with uterus, increases risk of uterine cancer). Within each stratum, randomized in a 2x2 factorial to control (no DM, placebo instead of HT), DM plus placebo, suitable HT, or suitable HT plus DM....
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- Winter '06