AMA Supports Public Registry For Clinical Trials, Outcomes
By a WALL STREET JOURNAL Staff Reporter June 16, 2004; Page
D2
The American Medical Association approved a policy to urge
the Department of Health and Human Services to develop a
public registry of all clinical trials and their outcomes.
As part of the policy, the AMA yesterday also requested that
powerful institutional review boards, or IRBs, require
registering in the proposed database as a condition for
allowing a clinical trial to proceed. IRBs are charged with
monitoring the treatment of participants in clinical trials.
The policy was drafted in response to concerns from
psychiatry groups, including the American Academy of Child
and Adolescent Psychiatry, over unpublished studies on
antidepressants and potential suicide risk, particularly
among children and adolescents
more but no url sorry
In article <e5f4a9c2.0406161033.12e58c64@posting.google.com>,
zwalanga@yahoo.com (Zee) wrote:
> AMA Supports Public Registry For Clinical Trials, Outcomes
>
> By a WALL STREET JOURNAL Staff Reporter June 16,
> 2004; Page D2
>
> The American Medical Association approved a policy to urge
> the Department of Health and Human Services to develop a
> public registry of all clinical trials and their outcomes.
>
> As part of the policy, the AMA yesterday also requested
> that powerful institutional review boards, or IRBs,
> require registering in the proposed database as a
> condition for allowing a clinical trial to proceed. IRBs
> are charged with monitoring the treatment of participants
> in clinical trials.
>
> The policy was drafted in response to concerns from
> psychiatry groups, including the American Academy of Child
> and Adolescent Psychiatry, over unpublished studies on
> antidepressants and potential suicide risk, particularly
> among children and adolescents
>
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>>>> more but
> >>>no url sorry
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Here tis...
http://online.wsj.com/article/0,,SB108733786503237992,00.ht-
ml?mod=todays_ us_personal_journal
Rest of Article below.
Unpublished clinical trial results are more likely to be
negative than published results, some studies have said.
Critics say doctors and patients need access to unpublished
studies to guide their decisions about medicines.
The AMA action boosts the pressure on drug companies to
release unpublished data from clinical trials.
Alan Goldhammer, associate vice president of regulatory
affairs for the Pharmaceutical Research and Manufacturers of
America, a trade group for drug makers, said it was too
early to say whether the group supports the AMA policy. Dr.
Goldhammer said questions remained about the proposed
registry. "What are the data elements?" he said.
In another step toward wider publication of negative trial
results, editors from some medical journals, including the
New England Journal of Medicine and JAMA, the AMA's journal,
said they have discussed a proposal that would require
companies to register in a clinical-trial database as a
condition of publication in their journals.
Such a requirement would mean "If you start a trial, then
you have to register it," said Catherine DeAngelis, editor-in-
chief of JAMA. The editors' discussion of a database
proposal was reported yesterday in the New York Times.
Some observers say medical journals themselves have a role
in the paucity of published negative trial results.
Journals, these observers say, have a bias for publishing
positive study results, that is, studies showing that a
treatment worked.
Drummond Rennie, professor of medicine at the University of
California-San Francisco and deputy editor of JAMA, said medical-
journal editors have urged the drug industry to agree to a
clinical-trial registry with little success. "I've been
pushing this for 10 years," said Dr. Rennie, who isn't part
of the committee of editors discussing the database
proposal. "It's only now that people are starting to pay
attention to this."
In the U.S., drug companies consider some of the data
proprietary. By law, the Food and Drug Administration can't
make the data public without drug company consent. A public
listing of all clinical trials isn't under the FDA's
authority and would be difficult to manage, said Rachel
Behrman, deputy director for medical policy at the FDA's
Center for Drug Evaluation and Research.
Write to newseditors@wsj.com
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