Missing trial data ‘threatens integrity of medicine’
pharmafile | January 4, 2012 | News story | Research and Development, Sales and Marketing | BMJ, clincial trial data, disclosure
Missing clinical trial data can harm patients and lead to needless costs for health systems, according to new research.
A series of papers published today by the British Medical Journal show that a large proportion of evidence from human medicines trials is unreported, despite rules making reporting ‘mandatory’.
The BMJ warns that missing data is a serious problem in clinical research and distorts the scientific record, so that clinical decisions cannot be based on the best evidence.
Controversy around data disclosure has been a major issue more than a decade, and the pharma industry has now signed up to full disclosure of trial data.
In an accompanying editorial, Dr Richard Lehman from the University of Oxford and BMJ clinical epidemiology editor Dr Elizabeth Loder, describe a “culture of haphazard publication and incomplete data disclosure”.
They call for more robust regulation and full access to raw trial data to allow better understanding of the benefits and harms of many kinds of treatment.
One study found that including unpublished data in published meta-analyses of drug trials often changed their results.
Two further studies show poor adherence to requirements for mandatory trial registration and timely sharing of results.
The US Food and Drug Administration Amendments Act of 2007 made publication of a results summary on ClinicalTrials.gov within 12 months mandatory for all eligible trials in the US “initiated or ongoing as of September 2007.”
But a new study by Ross and colleagues show that fewer than half of US National Institutes of Health funded trials are published in a peer reviewed journal within 30 months of completion. Meanwhile Andrew Prayle and colleagues found that only 22% of trials subject to mandatory reporting had results available within one year of completion.
“When the word ‘mandatory’ turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear,” write Lehman and Loder.
The paper’s authors argue that access to full trial data is needed to allow drugs to be independently assessed.
Two further studies also showed poor adherence to requirements for mandatory trial registration and timely sharing of results.
Other studies published today highlight the many difficulties researchers face when they try to assess the true harms and benefits of common interventions.
Lehman and Loder believe that concealment of data is ‘a serious ethical breach’ and that clinical researchers who fail to disclose data “should be subject to disciplinary action by professional organisations”.
“And this is no academic matter,” the authors added, “because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems”.
They conclude: “These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.”
In October, the Cochrane Collaboration, which publishes data reviews and meta-analyses, called for more transparency from pharma.
It argued that the industry only publishes positive data for its drugs and leaves out negative results for fear of damaging a drug’s potential.
Ben Adams
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