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."