Lack Of Compliance Put University Trials At Risk

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safety-first.jpgPatient health in clinical trials at the University of Medicine and Dentistry of New Jersey, a publicly funded institution, was jeopardized due to a lack of “research compliance capability,” according to a previously undiscosed portion of a federal monitor’s report, The Star-Ledger of New Jersey reports.

At issue is the university’s problem-plagued Office of Ethics and Compliance, and UMDNJ’s ability to audit research spending and report violations of clinical studies’ guidelines to the federal government. The confidential portion of the report found the ethics office, whose director recently resigned and is missing other key personnel, had failed in performing critical oversight of federal research grants, the paper writes. “UMDNJ admittedly has no research compliance capability at all and none is anticipated,” the monitor stated in the report.

The confidential report mentioned only one specific example of UMDNJ’s compliance failures - which the university also disputed. It involved a researcher conducting studies using Celebrex, which carries a Black Box warning. The monitor’s report said the physician, Todd Stitik, an osteoarthritis specialist at the UMDNJ-New Jersey Medical School in Newark, NJ, had placed patients at risk in a clinical research study and the university failed to file mandatory reports with the government. The report offered no details, the paper reports.

University officials said they had filed reports, and suspended Stitik’s research after a routine audit, but insisted the issues were administrative in nature. Denise Rodgers, UMDNJ’s executive vp of academic and clinical affairs, told the paper there was no evidence that any patients were ever endangered. Stitik didn’t return calls for comment and Rodgers says Stitik has voluntarily stopped participating in any research, according to the Ledger.

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  1. Ed,

    Interesting story, Id like to know what kind of shady bussiness occured in the clinical trials of antidepressants in children that were conducted at UMDNJ in 2000-2001. I hope its on the A.G.’s watch list.

  2. In August Drew Harris wrote an article about preventive medicine in the Star Ledger. He recommened an asprin every day for preentive medicine and that it would save money and would prevent illness. I was annyed with Drew Harris and called him to inform him that asprin causes many adverse side effecst that are extremely critical ad could cause premature death. He refuses to discuss the issues and was only interested in promote asprins.
    Drew Harris is an assistant professor at the UMDNJ School of Public Health, director of the Public Health Leadership Initiative for Emergency Response, assistant director of the NJ Center for Public Health Preparedness, past president of the NJ Public Health Association, and a podiatrist.
    Harris writes on public health issues such as Tuberculosis and bird flu, as well as the ways consumer choice, the media, zoning ordinance and other governmental and social policies affect community health.
    Harris is not alone, most research is conflict the issues of the health of all Americans

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