Medico–Legal Cases and Statistics
5
Joseph L. Gastwirth,
Joseph L. Gastwirth
George Washington University, Washington, DC, USA
Search for more papers by this authorJoseph L. Gastwirth,
Joseph L. Gastwirth
George Washington University, Washington, DC, USA
Search for more papers by this authorFirst published: 15 July 2005
Abstract
Medico-legal statistics concerns the use of data from animal studies, case–control and cohort studies and clinical trials in the context of the legal and regulatory system. Statistical findings are submitted to courts and governmental agencies to demonstrate that a new drug is safe and efficacious; exposure to a chemical in the workplace is harmful or not as well as in product liability cases. The validity of clinical findings that are used in advertisements claiming a product is superior to a competitor's or in support of a patent are subject to legal challenge. Recently, the adequacy of the information provided to patients who participate in clinical trials and similar studies has become an issue. This aspect of trials is especially important when the main investigators or the University have a financial interest in the outcome either through stock ownership or options or a royalty agreement.
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