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JAMA NEWS RELEASES
INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS WILL REQUIRE REGISTRATION OF CLINICAL TRIALS FOR PUBLICATION
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
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FOR IMMEDIATE RELEASE
Media Advisory: To contact JAMA Editor-in-Chief Catherine D. DeAngelis, M.D., or Commentary author Drummond Rennie, M.D., call Jann Ingmire at 312-464-2499.
INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS WILL REQUIRE REGISTRATION OF CLINICAL TRIALS FOR PUBLICATION
CHICAGO—The International Committee of Medical Journal Editors (ICMJE) issued a statement today that the 11 member journals will require, as a condition of consideration for publication, registration in a public trials registry for clinical studies involving human patients. The editorial outlining the new policy is published online simultaneously by all ICMJE member journals and was posted today on the JAMA website, www.JAMA.com. It will also appear in print in the September 15 issue of JAMA.
"Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product. Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making."
The ICMJE editors write that the trials must register at or before the onset of patient enrollment and that this policy applies to any clinical trial starting enrollment after July 1, 2005. "We speak only for ourselves, but we encourage editors of other biomedical journals to adopt similar policies." ... "The ICMJE does not advocate one particular registry, but its member journals will require authors to register their trial in a registry that meets several criteria. The registry must be accessible to the public at no charge. It must be open to all prospective registrants and managed by a not-for-profit organization. There must be a mechanism to ensure the validity of the registration data, and the registry should be electronically searchable." The editors list the further details they will require in a public registry in this editorial and note, that at present, only
www.clinicaltrials.gov, sponsored by the United States National Library of Medicine, meets the requirements.
"Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials." ... "Patients who volunteer to participate in clinical trials deserve to know that their contribution to improving human health will be available to inform health care decisions. The knowledge made possible by their collective altruism must be accessible to everyone. Required trial registration will advance this goal."
(JAMA. 2004;292:1363-1364. Available post-embargo at jama.com)
COMMENTARY: A GREAT IDEA SWITCHES FROM IGNORED TO IRRESISTIBLE
In an accompanying commentary, Drummond Rennie, M.D., a deputy editor of JAMA, writes that the idea of registering clinical trials has been in existence for many years, and the need for a comprehensive tracking system for reporting results is long overdue.
"One consequence of this lack of reporting is a persistent bias in favor of positive results and therefore in favor of the newer and more expensive treatments. Another consequence is that harmful effects found in unpublished trials disappear without a trace, since the U.S. Food and Drug Administration (FDA) has no mandate to report them to the public."
"Physicians and the public are now well aware of the importance of the registration of clinical trials," Dr. Rennie writes. "Progress is being made, but previous experience suggests that, because of inherent conflicts of interest, it is unlikely that industry will ever be able to establish a large, common, complete, useful, trustworthy, up-to-date, and easily accessible register maintained over the long term. Experience also demonstrates the enormous costs of not knowing about trials that bury data showing lack of benefit and that hide the harms of new treatments. The financial cost of an effective, independent, and transparent clinical trial register would amount to a tiny fraction of the costs of the trials themselves, or the costs of not knowing their results, while the personal costs of allowing the present chaotic system to continue are incalculable."
(JAMA. 2004;292:1359-1362. Available post-embargo at jama.com)
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org
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JAMA VIDEO NEWS REPORT
DIAGNOSIS OF ADULT ATTENTION DEFICIT HYPERACTIVITY DISORDER ON THE RISE
VIDEO:
B-ROLL:
Julie studying
AUDIO:
28-YEAR-OLD JULIE KNAPP HAS A HARD TIME FOCUSING ON HER PRE-MED
COURSES. SHE JUST FOUND OUT SHE HAS ADULT ATTENTION DEFICIT HYPERACTIVITY
DISORDER, OR ADHD.
VIDEO:
SOUNDBITE:
Julie Knapp
Adult ADHD Patient
In at: :12
AUDIO:
"I realized I needed more time, and I was frustrated...I went to my
doctor and told her there's got to be something because the only thing
that would get me help is a piece of paper saying that I do have or
that I was professionally evaluated for ADHD or something."
VIDEO:
B-ROLL:
Julie studying over GFX:
8,000,000 Adults with ADHD
4.4% of Adult Population
2nd Most Common Psychological Problem in Adults
AUDIO:
JULIE IS ONE OF MORE THAN EIGHT-MILLION ADULTS IN THE U.S. WITH ADHD.
THE DISORDER AFFECTS FOUR-POINT-FOUR PERCENT OF THE ADULT POPULATION...MAKING IT THE SECOND MOST COMMON PSYCHOLOGICAL PROBLEM IN
ADULTS AFTER DEPRESSION.
VIDEO:
SOUNDBITE:
Rafael Klorman, PhD,Professor of Psychology
University of Rochester, NY
In at: :42
AUDIO:
"There is a significant number of adults who come in for treatment in
adulthood, who have not been previously treated or diagnosed, who, as
it were, discover they have the condition, or are pressed by their
families or work environment."
VIDEO:
B-ROLL:
Dr. Klorman in office
Media Briefing Cover
AUDIO:
DR. RAFAEL KLORMAN IS A PROFESSOR OF PSYCHOLOGY AT THE UNIVERSITY OF
ROCHESTER. HE IS ONE OF THE FEATURED SPEAKERS ON ADULT ADHD AT AN
AMERICAN MEDICAL ASSOCIATION MEDIA BRIEFING IN NEW YORK.
VIDEO:
B-ROLL:
Julie walking on campus
AUDIO:
HE SAYS ADHD DEVELOPS IN CHILDHOOD BEFORE AGE SEVEN, BUT IS OFTEN NOT
RECOGNIZED IN INDIVIDUALS UNTIL THEY ARE IN MORE DEMANDING OR
STRESSFUL ENVIRONMENTS...ESPECIALLY IF THE PERSON HAS ABOVE AVERAGE
INTELLIGENCE.
VIDEO:
SOUNDBITE:
Rafael Klorman, PhD
AUDIO:
"When there is a pattern of continuous forgetting and failure to meet
deadlines, obligations and commitments, then an individual is having
serious difficulty."
VIDEO:
B-ROLL:
Dr. Klorman consulting with Julie
AUDIO:
DR. KLORMAN SAYS THERE HAS BEEN CONTROVERSY SURROUNDING THE DIAGNOSIS
OF ADULT ADHD BECAUSE THE CRITERIA HAS NOT YET BEEN SET. WHILE CHILDREN
MUST DISPLAY SIX OR MORE OF THE 18 SYMPTOMS OF HYPERACTIVITY...ADULTS
COULD BE DIAGNOSED ON THE BASIS OF AS FEW AS THREE OR FOUR.
VIDEO:
SOUNDBITE:
Julie Knapp
AUDIO:
"I do well in school, but I work very, very hard. I'm sometimes
forgetful at little bit. I can't sit still at times."
VIDEO:
B-ROLL:
Julie on campus
AUDIO:
JULIE'S TREATMENT HAS NOT BEEN DETERMINED YET. EVIDENCE SHOWS
STIMULANTS AND ANTI-DEPRESSANT MEDICATIONS USED WITH CHILDREN AND ADOLESCENTS ARE
ALSO EFFECTIVE IN ADULTS WITH ADHD.
VIDEO:
B-ROLL:
More Julie
AUDIO:
RESEARCHERS ARE ALSO WORKING ON A CLINICAL TEST TO HELP PINPOINT AN
ADHD DIAGNOSIS. A SIMPLE TEST COULD CHANGE THE LIVES OF MILLIONS OF
PEOPLE...SINCE ONLY FIFTEEN PERCENT OF ADULTS WITH ADHD ACTUALLY KNOW
THEY HAVE THE DISORDER.
THIS IS MARYLOU GALYO REPORTING.
