A Bill To Require Clinical Trial Disclosures

In response to the ongoing controversy over the lack of disclosure of clinical trial data, a Republican Congressman has introduced a bill that would require study results to be reported to ClinicalTrials.gov - the federal repository - regardless of whether the outcome is positive or negative. But there is more. The bill would also withhold federal grant funding to any entity that does not report results - and require repayment as a penalty.

“Public reporting of both positive and negative results will help other research be more effective and less duplicative," says Tom Green, a representative from upstate New York, in a statement in which he emphasizes the goal is to improve cancer research. "Enforcing the reporting requirement will not only lead to more available cancer research data, but also help every taxpayer dollar spent on research go further toward finding a cure.”

The move comes amid a growing fracas about unreported trial data. The Food and Drug Administration Amendments Act requires mandatory reporting of summary clinical trial results within one year of completion on ClinicalTrials.gov, a series of studies published in BMJ reported various problems. For instance, one paper found that only 22 percent adhered to the mandate (back story).

Last month, a pair of 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 has sparked debate about patient safety, the utility of meta-analyses for deciphering safety issues and obligations of drugmakers to physicians and patients. And a growing number of proposals have been suggested, such as creating an “external coordinating organization,” which would be independent and have legal resources to contract with drug and device makers for providing access to patient-level data, documents and case reports (read here).

Although current law requires research results conducted with federal money must be publicly reported, the enforcement mechanism is very weak and as a result not all research is reported, Reed notes in his statement. He adds, by the way, 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).

Hat tip to FDA Law blog