January 23, 2006

Orlistat gains FDA Advisory Committee approval

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

NCI and HL7 collaborate on clinical data messages

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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Zurich Biostatistics, Inc. (ZBI)

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