File this under ‘try and try again.’ A US Congressman has, once again, introduced legislation that would require study results to be reported to ClinicalTrials.gov - the federal repository - regardless of whether the outcome is positive or negative. And as before, the bill would also withhold federal grant funding to any entity that does not report results - and require repayment as a penalty.
“Knowing if a clinical trial failed is just as important as knowing if a trial is successful so millions of dollars are not wasted by other researchers attempting the same research efforts,” says Republican Tom Reed in a statement in which emphasizes the goal is to improve cancer research. “It’s vitally important all trial results are shared so that we might better understand the results to provide better care and advance our shared goal of finding a cure.”
As he did last year, Reed noted that, while current law requires research results conducted with federal money must be publicly reported, the enforcement mechanism is weak. As a result, not all research is reported. And so, he again stipulates that any violation would also carry another penalty - a grant recipient that does not report trial results will be ineligible for future grants (here is the bill).
To what extent this legislation becomes law is uncertain, at best. For one thing, the same bill went nowhere last time. And the ballparking suggests Reed is on a Quixotic journey. The odds of getting past committee is just 4 percent and the likelihood of passage is merely 1 percent (see this).
Just the same, his effort comes amid growing controversy over unreported trial data. As we noted last year, the Food and Drug Administration Amendments Act requires mandatory reporting of summary clinical trial results within one year of completion on ClinicalTrials.gov, but studies published in BMJ reported various problems. One paper found only 22 percent adhered to the mandate (back story).
Also, academics from the University of Minnesota School of Public Health examined 2,385 completed pediatric studies registered with ClinicalTrials.gov and found that only 29 percent were ever published. And only 53 percent that were financed by the National Institutes of Health were published. And publication that did occur, on average, took place two years after study completion (read this).
The issue, which has sparked debate about safety and obligations to physicians and patients, has embroiled several drugmakers. GlaxoSmthKline (GSK), for instance, recently launched a program to make available patient-level data from its clinical trials to independent researchers, which means other scientists will have an opportunity to study data and develop their own findings (see here and here).
The move came after the drugmaker paid a $3 billion fine to the US government to settle civil and criminal charges for bad behavior, some of which involved a failure to disclose data about its Avandia diabetes pill, which was linked to a higher rate of heart attacks and strokes than was known until data was later released (back story).
And Roche has agreed to make available data from all clinical trials for its Tamiflu treatment to a team of Cochrane Collaboration researchers. That move was made after the drugmaker agreed to widen access more generally for clinical trial information for its medicines in response to increased pressure from academics and a widely publicized online petition (read this).
Debates over trial data are not confined to the US, though. Recently, AbbVie (ABBV) and InterMune (ITMN) filed requests for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies concerning some of the drugs. The drugmakers are fighting over concerns that confidential information could be unfairly obtained by rivals (back story).
STORY ENDS HERE
Hat tip to Regulatory Focus