With the biotechnology and pharmaceutical industries reporting a record number of drugs in phase 3 clinical trials, a survey of US medical schools is critical of industry control over these trials. Some academic researchers say that investigators must have greater say in how the studies are carried out and how the findings are released to ensure proper treatment of patients and maintain high standards for research goals.
Researchers at Duke University (Durham, NC) surveyed 108 US medical schools and concluded that they are not abiding by publication guidelines that were set forth in 2001 by the International Committee of Medical Journal Editors (New Engl. J. Med. 347, 1335, 2002). This committee, consisting of the editors of 13 leading medical journals, was formed in 2001 to address concerns about a growing divergence between patient and commercial interest when it comes to clinical trials. The committee established guidelines recommending that authors disclose potential conflicts of interest and assure that investigators are fully responsible for the design of trials and control publication rights to clinical trial data—tasks that investigators are failing to accomplish, according to the new study.
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