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Researchers call for increased access to full results of medical studies

Jan. 14, 2013 — About $240 billion is spent globally on medical studies each year, but only about half of the results end up being made public for use by other researchers and doctors treating patients.


January 14, 2014
By Sheryl Ubelacker The Canadian Press

That lack of accessibility not only wastes precious research dollars,
but is also potentially harmful to patient care, argues a group of
researchers, who are calling for changes to ensure study results are
fully reported in medical journals.

"Overall, half of health
research, nothing from it is made public, not even the basic results or
the basic journal paper," said Dr. An-Wen Chan, a scientist at the
Women’s College Research Institute in Toronto.

And when research
is published, a study’s goals, methods and findings are usually
summarized, resulting in significantly incomplete information, said
Chan, lead author of one in a series of articles on research waste
published in this week’s Lancet.

"There are hundreds to thousands
of pages of research information that describe how the study was done,
as well as reporting all the analyses. And that is compressed into a
journal paper that’s less than 10 pages," he said.

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"So clearly
there’s some loss of information. And when you select what information
to report, as with any journal, the most interesting information is
selectively reported."

Chan said the strongest predictor of a
medical study being submitted for publication is finding positive
results for a drug, medical device or other intervention being tested.

When
results of research are negative — in other words, the drug or device
didn’t prove to be beneficial — researchers often don’t bother to submit
their study to a journal, he said.

But negative results are highly valuable in themselves, Chan stressed.

"To
know that something doesn’t work and we should not be treating our
patients with a particular intervention is important to know. It wastes
money, it wastes time and they’re potentially harmful if they don’t
work."

Chan and his co-authors from the U.S., Europe and
Australia cite several examples of incomplete study information leading
to wasted health-care spending or harm to patients.

For instance,
governments worldwide spent billions of dollars on Tamiflu
(oseltamivir) to treat influenza, especially during the 2009 H1N1
pandemic.

But the decision to stockpile the drug was based on
inadequate information, including clinical trials in which almost
two-thirds of patient data were not reported. As it turned out, Tamiflu
did not necessarily reduce hospital admissions or complications from flu
and its harmful side-effects were unclear.

"It’s really been
based on questionable evidence of whether it works or not, questionable
in the sense that regulators and independent researchers are unable to
fully evaluate whether it works or not because not all the data are
available," Chan said.

In the case of the blockbuster painkiller
Vioxx, exclusion of data by its maker Merck from studies submitted to
journals and to government regulators resulted in thousands of patients
who took the drug having heart attacks or strokes.

A subsequent
analysis by independent researchers that included full data from all
patient trials of the drug — obtained through a lawsuit — revealed the
risk of heart attack and stroke, leading to Vioxx being pulled from the
market by Merck in 2004.

Those scientists were able to show the
drug’s inherent dangers only because they obtained access to complete
information, Chan said.

"The tens of thousands of excess heart attacks and deaths that have been estimated could have been avoided."

In the Lancet article, Chan and co-authors make the following recommendations:

Research institutions and funding agencies should provide incentives
that reward scientists who provide full dissemination of study
materials.

– Researchers, funders, sponsors, government
regulators, research ethics committees and journals should develop and
adopt standards for the content of full study reports and for
data-sharing practices.

– These groups should endorse and enforce
study registration policies, wide availability of full study
information, and sharing of all patient-level health research.

Dr.
Andreas Laupacis, executive director of the Li Ka Shing Knowledge
Institute at St. Michael’s Hospital in Toronto, said the article
highlights an important issue that the public should be concerned about.

Patients
often agree to take part in research trials because they’re told it
could benefit society or future patients, said Laupacis, who was not one
of the authors.

"If we don’t then publish results, the benefit’s
not nearly what it should be and my sense is that (people) might be
less interested in entering trials," he said, adding that it also breaks
an "ethical contract" made between researchers and patients.

"I think it’s something that researchers will need to solve themselves, hopefully with a bit of a push from the public."


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