Clinical trials in other countries

liver411

June 21, 2010

Concern Over Foreign Trials for Drugs Sold in U.S.
By GARDINER HARRIS

WASHINGTON — Medical ethicists have worried for years about the growing
share of new drugs whose human trials took place in foreign countries where
federal auditors could not make sure patients were protected, but no one knew
how big the potential problem was.
But according to a report by Daniel R. Levinson, the inspector general of the
Department of Health and Human Services, 80 percent of the drugs approved for
sale in 2008 had trials in foreign countries, and 78 percent of all subjects
who participated in clinical trials were enrolled at foreign sites.
The report is scheduled to be released publicly on Tuesday, but a copy was
obtained by The New York Times.
Ten medicines approved in 2008 were tested entirely abroad with not a single
test patient in the United States, the report said.
In many cases, foreign trials provide invaluable information proving that
drugs are effective in a variety of ethnic groups. Mr. Levinson’s report
found that most foreign clinical trial sites and subjects were in Western
Europe, where ethical controls over research are generally as robust as those
in the United States.
But the report found that Central and South America had the highest number of
subjects per site and accounted for 26 percent of all subjects enrolled at
foreign trial sites. In 2008, the Food and Drug Administration inspected 1.9
percent of domestic clinical trial sites, while just 0.7 percent of foreign
clinical trial sites were similarly audited. Mr. Levinson’s investigators
found that the F.D.A. was 16 times more likely to audit a domestic site than a
foreign one.
Mr. Levinson pointed out that the agency was often unaware of foreign clinical
trials as they were being conducted. As a result, federal regulators have no
ability to ensure that patients in these trials are being protected while the
research is continuing.
Instead, federal auditors can go back to the trial sites only after a company
submits an application to sell the medicine in the United States — often
years after the trial ceased.
Even among trials that are registered with the F.D.A. before they begin, the
share of foreign investigators has more than doubled to roughly a third of
investigators in 2008 from about 13 percent in 1998.
The report “highlights a very frightening and appalling situation,” said
Representative Rosa DeLauro, Democrat of Connecticut. “By pursuing clinical
trials in foreign countries with lower standards and where F.D.A. lacks
oversight, the industry is seeking the path of least resistance toward lower
costs and higher profits to the detriment of public health.”
The F.D.A. did not provide an immediate comment.
The agency has long been plagued by budget shortages in its inspectional
program, and audits of foreign clinical trial sites are expensive, costing
upwards of $40,000 each. An increasing share of drugs are tested at multiple
sites, with each investigator having only a limited number of subjects. So the
share of data that can be audited at a single site has declined, making audits
less representative and less useful.
The agency has also been challenged by its own poor record-keeping and data
submissions from drug makers that do not adhere to standardized formats. For
instance, the F.D.A. was unable to provide Mr. Levinson’s investigators with
detailed clinical trial data for 29 of the 129 of the approved applications in
2008. For eight of the applications, the agency could not locate any part of
the application.
Mr. Levinson suggested that the agency demand that drug companies submit their
applications in a standardized electronic format. A database controlled by the
F.D.A. of foreign clinical trial sites would help identify sites and
investigators for audits, he wrote.
“As sponsors increase the number of foreign clinical trials in support of
F.D.A. marketing applications, the agency’s current method of using
inspections to ensure human subject protections and data validity is becoming
increasingly strained,” Mr. Levinson wrote.
To cope, he encouraged the F.D.A. to develop more cooperative inspection
agreements with foreign governments, inspect more clinical trials in more
countries and encourage companies to register their foreign trials before they
are conducted.
In comments in the report, the agency largely agreed with Mr. Levinson’s
suggestions and said it was testing a new computer system that would help
track foreign clinical trial sites.
“I think this report just confirms the potential problems with foreign
trials,” said Dr. Adil E. Shamoo, editor in chief of Accountability in
Research, a journal about research ethics. “There is less liability, patient
recruitment is far easier, the concept of informed consent is not well
established, and it’s cheaper.”



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