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Registered clinical trials make positive findings vanish
http://www.nature.com/news/registered-clinical-trials-make-positive-findings-vanish-1.18181?WT.mc_id=TWT_NatureNews
Registered clinical trials make positive findings vanish
A study showing a fall in positive trial results after the roll-out of clinicaltrials.gov attracted much attention on social media.
Chris Woolston
13 August 2015
The launch of the clinicaltrials.gov registry in 2000 seems to have had a striking impact on reported trial results, according to a PLoS ONE study1 that many researchers have been talking about online in the past week.
A 1997 US law mandated the registry’s creation, requiring researchers from 2000 to record their trial methods and outcome measures before collecting data. The study found that in a sample of 55 large trials testing heart-disease treatments, 57% of those published before 2000 reported positive effects from the treatments. But that figure plunged to just 8% in studies that were conducted after 2000. Study author Veronica Irvin, a health scientist at Oregon State University in Corvallis, says this suggests that registering clinical studies is leading to more rigorous research. Writing on his NeuroLogica Blog, neurologist Steven Novella of Yale University in New Haven, Connecticut, called the study “encouraging” but also “a bit frightening” because it casts doubt on previous positive results.
<snip>
Irvin says that by having to state their methods and measurements before starting their trial, researchers cannot then cherry-pick data to find an effect once the study is over. “It’s more difficult for investigators to selectively report some outcomes and exclude others,” she says.
Many online observers applauded the evident power of registration and transparency, including Novella, who wrote on his blog that all research involving humans should be registered before any data are collected. However, he says, this means that at least half of older, published clinical trials could be false positives. “Loose scientific methods are leading to a massive false positive bias in the literature,” he writes.
<snip>
Registered clinical trials make positive findings vanish
A study showing a fall in positive trial results after the roll-out of clinicaltrials.gov attracted much attention on social media.
Chris Woolston
13 August 2015
The launch of the clinicaltrials.gov registry in 2000 seems to have had a striking impact on reported trial results, according to a PLoS ONE study1 that many researchers have been talking about online in the past week.
A 1997 US law mandated the registry’s creation, requiring researchers from 2000 to record their trial methods and outcome measures before collecting data. The study found that in a sample of 55 large trials testing heart-disease treatments, 57% of those published before 2000 reported positive effects from the treatments. But that figure plunged to just 8% in studies that were conducted after 2000. Study author Veronica Irvin, a health scientist at Oregon State University in Corvallis, says this suggests that registering clinical studies is leading to more rigorous research. Writing on his NeuroLogica Blog, neurologist Steven Novella of Yale University in New Haven, Connecticut, called the study “encouraging” but also “a bit frightening” because it casts doubt on previous positive results.
<snip>
Irvin says that by having to state their methods and measurements before starting their trial, researchers cannot then cherry-pick data to find an effect once the study is over. “It’s more difficult for investigators to selectively report some outcomes and exclude others,” she says.
Many online observers applauded the evident power of registration and transparency, including Novella, who wrote on his blog that all research involving humans should be registered before any data are collected. However, he says, this means that at least half of older, published clinical trials could be false positives. “Loose scientific methods are leading to a massive false positive bias in the literature,” he writes.
<snip>
2 replies
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