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Study says schools often stray from set guidelines
Academic institutions routinely engage in industry-sponsored research that fails to adhere to International Committee of Medical Journal Editors (ICMJE) guidelines regarding trial design, access to data, and publication rights, say researchers in a study published in the Oct. 24 issue of the New England Journal of Medicine.
Last winter, researchers from Duke University Medical Center and the Duke University School of Law in Durham, NC, interviewed officials at 108 U.S. medical schools about provisions in their institutions’ agreements with industry sponsors of multicenter clinical trials. The researchers also asked a subgroup of the respondents about coordinating-center agreements for such trials.
Some of the study findings include:
- Only 10% of contracts covered how data are collected and monitored, and only 5% covered how data are analyzed and interpreted.
- Less than 1% of contracts guaranteed that results would be published and that an independent committee would have control over that. However, 40% of contracts addressed editorial control of manuscripts.
- Only 1% of contracts required an independent board to monitor patient safety.
"Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed," the researchers say.
Bioterrorism funding up, clinical relevance goal
Governmental funding for biodefense will rise from $225 million in 2002 to $1.7 billion in 2003, says Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIAID).
The NIH and affiliated researchers are aggressively pursuing cutting-edge research — such as gene sequencing — with the major bioterrorism agents. In addition to NIAID, the research is being conducted by the Department of Defense and the Centers for Disease Control and Prevention. The genetic research has immediate implications for immunology and host response, he says.
The goal of all research, says Fauci, is to produce clinically relevant results. "The conversation [with the White House] was that we’ll give you money and you can do your basic research, but at the end of a few years I don’t want you to come to me when I ask what you’ve accomplished and say, We’ve learned a lot.’ That is not the right answer. The right answer is we have vaccines, we have therapeutics, and we have diagnostics. That’s the mode we’re in."
Studies under way include vaccine development for anthrax, Ebola, Lhasa, and Marburg, an examination of bacterial phages (viruses that can specifically invade and kill bacteria), and expansion of existing diagnostic and treatment modalities.
Study says schools often stray from set guidelines; Bioterrorism funding up, clinical relevance goal.
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