Spine Editor Proposes National Clinical Trials Consortium

Newswise — 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 reforming the way medical research is performed in the United States, according to a proposal by Dr. James N. Weinstein, Editor-in-Chief of Spine.

Outlining his plan in an editorial in the Jan. 1 issue of Spine, Dr. Weinstein writes, "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(s) trial group(s) conflicted in mission and purpose." Dr. Weinstein is Professor and Chairman of Orthopaedic Surgery and Professor in Community & Family Medicine and Senior member of the Center for the Evaluative Clinical Sciences at the Dartmouth-Hitchcock Medical Center and Dartmouth Medical School.

Low-quality medical research is a key contributor to the fundamental flaws of the U.S. health care system, Dr. Weinstein believes. 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 Dr. Weinstein. "Inadequate follow up and failure to report negative findings undermine the very scientific process that has advanced medicine."

How to reform the system? Dr. Weinstein proposes the establishment of a National Clinical Trials Consortium as an "earnest collaboration of everyone who cares deeply about the state of our health care environment." The Consortium would be formed and run by physicians, surgeons, and Ph.D. scientists, with oversight by a board including representatives from government, professional societies, private foundations, industry, and the public. 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 Consortium's collaborative structure would allow studies to recruit patients and achieve results more quickly. Open dissemination of the results to interested public and private groups would be required. Dr. Weinstein points out, "This structure would serve to increase credibility and validity and thereby lessen medical liability."

"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," Dr. Weinstein concludes. As a next step, he suggests a summit meeting to discuss the concept. He comments, "The issue is important enough, and the public health and financial implications large enough, to warrant serious discussions regarding models and infrastructures for medical research reform."