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Clinical Trial Research
Risk of death from rofecoxib in some trials may have been misrepresented by study sponsor
May 3rd, 2008
A comparison of internal company documents, data submitted by the company to the FDA, and published clinical trial results indicates that the risk-benefit profile of rofecoxib in clinical trials involving patients with cognitive impairment may have been misrepresented by study sponsor Merck, according to an article in the April 16 issue of JAMA. "Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data. Selective reporting of the results of clinical trials can misrepresent the risk-benefit profile of drugs," the...
Source: Law & Health Weekly (2008-05-03)
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