Many drug trials never see publication: Results of most drug trials are unreported, inaccessible to clinicians and patients

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Many drug trials never see publication

Results of most drug trials are unreported, inaccessible to clinicians

and patients, a new study confirms

Ehrenberg

Web edition : Monday, November 24th, 2008

http://www.sciencenews.org/view/generic/id/38881/title/Many_drug_trials_never_se\

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Many drug trials never see publication

Results of most drug trials are unreported, inaccessible to clinicians

and patients, a new study confirms

By Ehrenberg

Web edition : Monday, November 24th, 2008

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VITAL INFORMATIONDrug information may be missing from FDA files,

highlighting the need for disclosure in scientific literature.Food and

Drug Administration

Patients asking their doctors if a new drug is right for them would do

well to also ask for supporting evidence. Conclusions about drug safety

and effectiveness in reports submitted to the FDA are sometimes changed

to favor the drug in the medical literature, a new analysis finds. And a

quarter of submitted drug trials were never published at all,

researchers report in the Nov. 25 PLoS Medicine.

Information published in journals is the most accessible to health care

professionals and also drives marketing of new drugs. The new study

suggests that this information is incomplete and biased, says health

policy expert Bero of the University of California, San Francisco,

who led the study.

An-Wen Chan, who wrote an accompanying commentary but was not involved

with the work, says he does not think health care providers will be

surprised to learn of suppression and inaccurate reporting of new drug

information.

" These new findings confirm our previous suspicions that this is

happening on a much broader systemic level. It shows that information is

unavailable to those who really need it the most --- the clinicians and

the researchers, " says Chan, of the Mayo Clinic in Rochester, Minn. " If

we take the view that research on humans is ethical, is allowed based on

an assumption of public good, then all clinical trial information should

be publicly available. "

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RESULTS OF TRIALSOf 164 trials investigated in a recent study, trials

with favorable results were more likely to be published than those with

unfavorable results.Food and Drug Administration

Drug manufacturers are required to submit all their studies to the U.S.

Food and Drug Administration as part of new drug applications. That's

the last step in drug development, following testing on animals, trials

with healthy people, and larger trials with sick and healthy people.

Ideally, if the drug receives FDA approval, all the clinical information

associated with the drug is made publicly available so health care

providers can make informed decisions about treatment. This is typically

done by publishing in the scientific literature.

The new analysis examined 164 trials for 33 new drugs that were approved

by the FDA from January of 2001 to December 2002. By June 2007, one

quarter of the trials were either published only in a partial form ---

as an abstract, or part of a pooled publication --- or were not

published at all. The unpublished trials were predominantly those with

unfavorable results, the researchers report.

The new study could not determine if sponsoring drug companies had

prohibited investigators from publishing, but some investigators told

the research team that they were eager to publish but were unable to

coordinate their efforts with the drug company.

Development of one drug can require several trials. But among the drugs

for which findings were published in the scientific literature, only 52

percent disclosed results from every trial.

Trial outcomes reported in the FDA applications often differed from what

was reported in the scientific literature. Outcomes are predefined

measures that indicate, for example, whether the new drug is more

effective than existing treatments, or whether a drug has other effects

on a patients' health. In addition to the 138 outcomes reported in the

new drug applications, journal articles reported 15 more, all favoring

the new drug. Only half of the 43 outcomes that did not favor the new

drugs in the FDA applications were reported in the scientific

literature. Ten conclusions were actually changed to favor new drugs,

the researchers report.

The study highlights the need for full disclosure of all results related

to new drugs, says Chan. In September, a federal law went into effect

that mandates registration of all clinical trials in a publicly

accessible database, ClinicalTrials.gov, run by the National Institutes

of Health. This is a great step forward, says Bero, but there are still

holes --- safety data, for example, aren't required, nor is reporting of

all data.

Others have suggested that the review boards, required for institutions

that conduct drug research with federal funding, could insist that

results be published in full, says Scoggins of the Fred Hutchinson

Cancer Research Center in Seattle.

" The novelty of this article isn't that it reveals publication bias ---

it's just been hard to find the data to prove it, " Scoggins says. " The

evidence is just now trickling in of just how bad it is. "

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