Originally published April 20 2014
Clinical trial results more honest on government website than in science journals
by J. D. Heyes
(NaturalNews) An Oregon Health & Science University (OHSU) analysis published recently in the Annals of Internal Medicine found that medical researchers very often presented the findings of their clinical trials in a different way on a federal government website then they did in the medical journals where their studies were published.
The reports of researchers in peer-reviewed medical journals, in fact, were very often more favorable to the drug or intervention being examined than the reports on the government website -- ClinicalTrials.gov -- which requires data for specific categories, says the university analysis.
'Serious adverse events' left out of journal reports
According to a press release of the findings:
One of the most notable discrepancies: Of the 84 clinical trials the researchers looked at where a "serious adverse event" was reported on ClinicalTrials.gov, 33 of those trials reported fewer adverse events in the medical journals than they had reported to the government website. In 16 of those cases, no adverse events were reported in the journals.
OHSU researchers said their analysis demonstrated the ongoing problem with inaccurate and sometimes biased reporting in medical journals. But it also showed that the government website could be another viable source for objective medical information.
"There's a general recognition that adverse events historically haven't been reported consistently in the medical literature. And underreporting of these events is a major concern because it can distort how health care providers balance the benefits and harms of drugs and other medical interventions for their patients," said Daniel Hartung, Pharm.D., M.P.H., associate professor in the Oregon State University/OHSU College of Pharmacy and lead author of the study. "But our analysis also seemed to show that ClinicalTrials.gov could be a good alternative for consumers and health care providers to get comprehensive information about a drug or medical intervention."
The researchers examined 110 medical trials which had been completed by Jan. 1, 2009, and which had also been reported on ClinicalTrials.gov. Congress required that, after September 2008, many drug clinical trials and medical interventions report their findings and results to the website, as a way to give consumers and healthcare providers better information about the results of said trials.
For their study, the OHSU researchers only examined trials completed by 2009 to allow for the clinical trial results to later be published in medical journals, for comparison.
Of the 110 trials the researchers looked at, most were sponsored by industry -- paid for by the pharmaceutical industry or medical companies, for instance. The analysis found that inconsistencies between information on the same trial at ClinicalTrials.gov and in the medical journals were common.
That said, in most cases the discrepancies were small and did not necessarily affect the statistical significance of the result.
More from the University's press release:
Another discrepancy between the two areas of reporting came in how deaths that were part of the clinical trials were reported. In that circumstance, deaths seemed to be underreported or inconsistently report on ClinicalTrials.gov. For instance, in 17 percent of the trials that did not reported deaths on ClinicalTrials.gov, deaths were reported in the journal article on the trial. Prior studies have indicated ClinicalTrials.gov does not have a uniform way of reporting deaths and that may lead to inconsistencies.
"This is the most comprehensive study of ClinicalTrials.gov to date," said Mark Helfand, M.D., M.S., M.P.H., professor of medicine and medical informatics and clinical epidemiology at the OHSU School of Medicine, and a co-author of the analysis/study. "It shows that patients and clinicians could use it to find information that is not available in the published literature, particularly to get more complete information about the harms of various treatment options. It also shows that, to best serve the public, death rates and some other items in ClinicalTrials.gov should be audited to keep them up to date."
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