Lacking drug trial data a health threat
Source: Agencies |
January 5, 2012, Thursday
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Print Edition
Print Edition
UNREPORTED data from early trials of experimental medicines in humans can result in harm to future patients and needless costs for health systems, according to scientists writing in the British Medical Journal yesterday.
In a series of studies for the BMJ on the extent to which clinical trial data are made public, researchers found a large proportion of evidence was unreported and inadequate.
"Missing data is a serious problem in clinical research," the scientists said. "It distorts the scientific record, so that clinical decisions cannot be based on the best evidence."
New rules set out in 2007 by the US Food and Drug Administration, which regulates the world's largest market for drugs, made publication of a results summary on the website ClinicalTrials.gov within 12 months mandatory for all eligible trials after September 2007.
As of 2008, the global drug industry body the International Federation of Pharmaceutical Manufacturers and Associations also required its members - including the world's major drugmakers - to register all trials in patients and publish a summary of the results.
But in the BMJ studies, Richard Lehman from Britain's Oxford University and the BMJ's clinical epidemiology editor Elizabeth Loder described finding a "culture of haphazard publication and incomplete data disclosure."
"The current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine," they wrote.
In a series of studies for the BMJ on the extent to which clinical trial data are made public, researchers found a large proportion of evidence was unreported and inadequate.
"Missing data is a serious problem in clinical research," the scientists said. "It distorts the scientific record, so that clinical decisions cannot be based on the best evidence."
New rules set out in 2007 by the US Food and Drug Administration, which regulates the world's largest market for drugs, made publication of a results summary on the website ClinicalTrials.gov within 12 months mandatory for all eligible trials after September 2007.
As of 2008, the global drug industry body the International Federation of Pharmaceutical Manufacturers and Associations also required its members - including the world's major drugmakers - to register all trials in patients and publish a summary of the results.
But in the BMJ studies, Richard Lehman from Britain's Oxford University and the BMJ's clinical epidemiology editor Elizabeth Loder described finding a "culture of haphazard publication and incomplete data disclosure."
"The current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine," they wrote.
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