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DMS Chair Proposes New Collaborative Approach for Clinical Trials

James Weinstein
James Weinstein

A National Clinical Trials Consortium — formed of an unprecedented collaboration among government, industry, and medical research institutions — could be a "tangibly and conceptually constructive" step toward improving medical research procedures in the United States, according to a proposal by James Weinstein, professor of orthopaedic surgery and community and family medicine at Dartmouth Medical School.

Low-quality medical research is a key contributor to the fundamental flaws of the U.S. health care system, believes Weinstein, who is also chairman of the orthopaedics department at Dartmouth-Hitchcock Medical Center. Industry-sponsored clinical trials, designed to get products to market as fast as possible, are subject to bias, while close affiliations between industry and academic research institutions raise concerns about conflict of interest. "We continue to bring new technologies into practice under cover of poorly designed studies that are often underpowered and without clearly defined endpoints relevant to the question at hand," writes Weinstein. "Inadequate follow up and failure to report negative findings undermine the very scientific process that has advanced medicine."

Editor-in-chief of Spine, Weinstein outlined his vision in the journal's January 1 issue. "My hope is that a National Clinical Trials Consortium with broad geographic representation would allow us to bring the focus of our profession back to serving our diverse patient needs while minimizing the costs incurred by the current extensive network of various individual trial group(s) conflicted in mission and purpose," he wrote.

In order to reform the system, Weinstein proposes the establishment of a National Clinical Trials Consortium that would be formed and run by physicians, surgeons, and Ph.D. scientists. A board of representatives from professional societies, government, private foundations, industry, and the public would oversee the Consortium's progress. Funding would come from industry, health care payers, governmental agencies, foundations, and other stakeholders.

The Consortium would provide a system of "checks and balances" in the conduct of medical research. A major focus would be identifying the most pressing and relevant clinical questions and designing studies to answer them. The Consortium would recruit innovative researchers with expertise in addressing the most problematic aspects of designing, conducting, and reporting clinical research. Its primary function "would be to promote and direct high-quality clinical trials less susceptible to conflict of interest, affording them more face validity and almost certainly less bias."

The collaborative structure of the Consortium would allow studies to recruit patients and achieve results faster than the current pace of clinical trials. Open dissemination of the results to interested public and private groups would be required to increase credibility and validity and thereby lessen medical liability, according to Weinstein.

Weinstein emphasizes his proposal is only a starting point. Major investments in time and resources would be required, along with a proactive change in the way technology is adapted by physicians and surgeons. He concludes, "A National Clinical Trials Consortium offers industry, our profession and our patients the results we all want, an altruistic, selfless means to determine the most effective treatment alternatives."

By ANDY NORDHOFF

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Last Updated: 12/17/08