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January, 2006
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January 23, 2006
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Michael Palmer GlaxoSmithKline may have engineered the first Rx-to-OTC switch of a weight-loss drug, and, indeed, orlistat (brand name Alli, pronounced "ally"), if finally approved by the FDA for over-the-counter (OTC) use, will be the only drug for weight loss that is FDA-approved for consumer use without a prescription. ZBI's Dr. Cecilia A. Hale was Glaxo's lead statistician in preparing for the January 23 FDA Advisory Committee meeting that approved orlistat. GSK also assigned Dr. Hale a key role at the Advisory Committee meeting. [Continue]
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January 23, 2006
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Michael Palmer Language is infinite . . . , but data can't be. And, that's the problem. How many ways can a case report form in a clinical trial ask for an evaluation of a patient's tumor? Pathology, longest dimension, change since last evaluation, location, and on and on. How many ways can that data be represented? Free text, coded text, numerically, as an image, etc., etc. Consider multi-national clinical trials with investigators, patients, and sponsors using multiple languages. Next, automate case report form creation and data transmission. Where are you now? At the eDCI--electronic Data Collection Instrument. [Continue]
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January 16, 2006
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Michael Palmer What's on your wishlist for electronic clinical trials management software (eCTM)? Easy study set-up? Automated workflows? Electronic data capture (EDC) of study data? XML-based architecture? Web-based? Capable of handling the full clinical trial lifecycle? Since we're making wishes, let's wish for software that's scalable in both costs and capabilities. That means that users get just what they need and pay for just what they get. In other words, the technology and cost overhead are proportional to the user's needs. It is not beyond the reach of small medical research organizations and there is the functionality and capacity to support major clinial trials efforts. OK--no one's doing all this yet, let's call the wishlist a "business model" and pitch it to venture capitalists for funding, right? Well, first, take a look at what the U.S. Government's doing to support clinical trials that are ongoing in one of its healthcare enterprises. [Continue]
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January 12, 2006
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Michael Palmer For the pharmacokinetics of many drugs, genotype to genotype variability often exceeds the conventional bioequivelence window of 80-125%. Nevertheless, drug development, government-regulated drug labeling, and clinical practice do not systematically incorporate pharmacogenetic data into decision-making. Systematic use of standardized clinical trials designs for examining pharmacogenetics will help to bring the benefits of molecular medicine to patients. [Continue]
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January 11, 2006
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Michael Palmer Some 100,000 deaths in the United States each year are due to adverse drug reactions and these deaths are the tip of an adverse drug reaction iceberg of some 2 million cases. In the realm of drug efficacy, most major drugs are effective in only 25 to 60 percent of patients. These statistics are the public health face of the biology of variability in drug response. Environmental, genetic, and disease factors have important roles in the absorption, distribution, metabolism, and excretion of a given drug and, consequently, these factors have important roles in the safety and efficacy outcomes for patients taking a given drug. [Continue]
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January 10, 2006
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Michael Palmer The lifelong economic benefits of a college education are well-known, but what about lifelong health benefits? Research indicates that the risk of dementia is inversely associated with education as well as with other factors such as social class and occupation. There is a common thread among these protective factors. [Continue]
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January 2, 2006
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Michael Palmer Let's not forget, and let's feel proud about, how important our day-to-day work is for improving the health, welfare, and lives of humankind, whether we work in industry, government, or non-governmental organizations. [Continue]
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