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 The rules, which are open for public comment until Feb. 19, apply to
the database ClinicalTrials.gov, operated by the National Institutes
of Health (NIH).
Researchers are documenting ever-more cases in which unfavorable
study results are withheld from the public.
"The proposals take important steps toward greater transparency, but
there are also disappointments," said Kay Dickersin, director of the
Center for Clinical Trials at the Johns Hopkins Bloomberg School of
Public Health.
One change would require that human studies funded even partly by
the NIH, including surgical procedures and behavioral therapies such
as for obesity, not only be registered at ClinicalTrials.gov but
also report summary results. Previously, there was no such
requirement.
Absent NIH funding, clinical trials conducted on experimental or
approved drugs regulated by the U.S. Food and Drug Administration
would not have to report safety data.
But researchers would be required to report other results, a
significant expansion of the current requirement, which allows data
to remain secret if, for instance, they find a drug or other therapy
to be ineffective.
"This proposed rule would close an important gap" by making
additional information about clinical trials publicly available, FDA
commissioner Dr. Margaret Hamburg said in a statement.
In a 2013 study, scientists found that of hundreds of trials they
examined half never published results. An analysis of scores of
studies of the influenza drug Tamiflu reported in April that
published studies painted the drug as safer and more effective than
confidential clinical-trial reports submitted to regulators.
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Johns Hopkins' Dickersin, who has criticized the lack of
transparency in clinical trials, praised the requirement that
studies of additional uses of approved drugs, such as whether a
neuralgia drug also works against migraines, report results.
Currently, doctors are permitted to prescribe such "off-label" use
of approved drugs, never knowing whether a study showed they do not
work for the additional disorder.
One disappointment, Dickersin said, is that the proposals do not
require researchers to reveal details of study protocols, such as
what endpoints - heart attacks, for example - it aims for and how.
That might let a manufacturer conceal unfavorable results.
Of the 178,000 studies registered on ClinicalTrials.gov, summary
results have been posted for 15,000.
(Reporting by Sharon Begley; Editing by Jonathan Oatis)[© 2014 Thomson Reuters. All rights
reserved.] Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
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