Under the Microscope: The Impact of New Regulations on Clinical DevelopmentIt's been five years since we reached a "tipping point" in attitudes toward drug safety with Merck's withdrawal of Vioxx®. We're now operating in a new era of drug safety marked by heightened scrutiny, public skepticism, and industry responsibility. |
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Observational Databases and RegistriesThe outcomes and costs associated with medical innovations are critical issues for society. New therapies are required to be efficacious, safe, and effective in usual practice. While randomized clinical trials are the standard for safety and efficacy of medication or device, results may not reflect treatment effectiveness in the community. |
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ICON ProfileDeborah P. Lubeck, Ph.D. -
Vice President, Health Economics and Outcomes Research,
Lifecycle Sciences Group, ICON Clinical Research |
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Did you know?Fast Facts. |
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