Journal Editors Call for Clinical Trials Registry

Better public access to trial details will be prerequisite to publication

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MONDAY, May 23, 2005 (HealthDay News) -- Editors of some of the world's leading medical journals have banded together to demand that researchers register key information on their clinical trials in a central public registry.

In a joint editorial published Monday, members of the International Committee of Medical Journal Editors (ICMJE) -- which includes the editors of the Journal of the American Medical Association, The Lancet and the New England Journal of Medicine -- say that, starting this July, only trials entered in such a public registry will be considered for publication in their respective journals.

This registry should be free, electronically searchable, and easily accessed by the public. Descriptions of each trial should include clear, meaningful information as to the treatment under study, the editors added.

Monday's editorial, published on the websites of all 11 ICMJE journal members, reiterates a previous call for more open disclosure first made in a joint editorial published last September.

"Our first editorial was a wake-up call for researchers, trial authors and sponsors," Dr. Harold Sox, editor of the Annals of Internal Medicine, said in a prepared statement. "This editorial reaffirms our intent and tells researchers what they must do to meet our requirements for editorial review and subsequent publication."

The ICMJE call for better accountability of clinical trials was seconded by Dr. David J. Kupfer, chairman of the department of psychiatry at the University of Pittsburgh School of Medicine.

In a speech scheduled for presentation Monday at the American Psychiatric Association's annual meeting, in Atlanta, he said researchers need to be more rigorous in how they design, conduct and report clinical trials to avoid confusing and unnecessarily alarming the public.

"What is a risk? What is a risk factor? Are all risk factors equal? What is the threshold for true clinical significance? The general public can't be expected to understand these questions, let alone know the answers. Yet, ultimately, they are the ones who are most affected by journal articles that include words like 'risk' that even some of us working in research are not accurately defining," Kupfer said in a prepared statement.

Even though they don't read the medical journals, the general public bases important health-care decisions and lifestyle changes on research published in those journals, especially when studies discuss health risk factors, Kupfer pointed out.

In addition, published studies are often interpreted by the news media, clinicians and policy makers as calls to action, he said. Then, months or years later, the results of these same studies are often refuted or challenged by subsequent research.

As an example of potential confusion caused by published studies, Kupfer pointed to a major news story of the past year: studies that found that antidepressants were linked to increased suicide risk in children and teens.

"In truth, these studies, which received much attention from the press, overestimated the risk and underestimated the benefit of prescribing antidepressants to children and teens. But clinicians and parents alike were at a loss to understand their meaning," Kupfer said.

"How do we sort out these contradictions? We have a responsibility to the general public, who on a daily basis hear about new findings or ways to reduce risks of disease that are extrapolated from a study and then reported by the media. But too often, these reports are confusing or include data taken out of context and offer conflicting information about what puts us at risk for diseases," he said.

The Pittsburgh expert urged researchers to be more precise in defining, understanding and evaluating types of risk factors, and to be more discerning in assessing other published studies that may form the basis of their research or which they may cite in their reports.

More information

The American Medical Association has more about medical research.

SOURCE: American College of Physicians, news release, May 23, 2005; University of Pittsburgh Medical Center, news release, May 23, 2005


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