FDA Gets More Authority Over Clinical Trial Reporting

FDA Gets More Authority Over Clinical Trial Reporting

September 27th, 2012 // 2:19 pm @



Here is an interesting development in the ongoing controversy over reporting clinical trial data in all its glory to the federal government. The US Department of Health & Human Services has transferred authority to the FDA to oversee information that is filed with ClinicalTrials.gov – the clinical trial registry data bank – and seek out those who fail to file, or file misleading or false data, according to a statement in the Federal Register (see here).

Of course, the FDA reports to the HHS, but the move is likely to be more than symbolic, given the scandals that have ensued in recent years over a failure to provide complete trial data. Examples include the Avandia diabetes pill sold by GlaxoSmithKline, which recently paid a $3 billion settlement, partly for failing to report safety data (read this). And evidence that Merck hid risks associated with its Vioxx painkiller continues to emerge (look here).

The notice says that the FDA now has a green light to pursue “…any clinical trial information (that) was not submitted as required under (federal law) or was submitted but is false or misleading in any particular, and to notify the responsible party and give such party an opportunity to remedy non-compliance by submitting required revised clinical trial information not later than 30 days after such notification.” The transfer of authority was first reported by Regulatory Focus.

In recent years, studies have shown that some clinical trial data often goes unreported. A 2009 analysis published in PLoS Medicine found that data mandated for reporting to ClinicalTrials.gov was nearly 100 percent, but reporting of optional data and publication rates were low. For instance, 53 percent reported trial end dates, 66 percent reported primary outcomes and 87 percent reported trial start dates.

Among a subsample of trials examined, those primarily sponsored by industry, or 40 percent, were less likely to be published when compared with trials not sponsored by industry or government sponsored trials, or 56 percent, but there was no significant difference when compared with government-sponsored trials. “Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited,” the authors wrote (read here).

Earlier this year, a series of papers in BMJ found a host of problems with reported trial data. One paper examined unpublished evidence of existing meta-analyses of nine drugs approved by the FDA in 2001 and 2002, but found identical estimates of drug efficacy in only three of 41 cases, or 7 percent. Estimates of efficacy were split evenly split in the remaining cases when unpublished FDA trial data was examined.

Another example: The Food and Drug Administration Amendments Act (FDAAA) requires mandatory reporting of summary clinical trial results within one year of completion on ClinicalTrials.gov. But one BMJ paper found that only 22 percent adhered to the mandate. Generally, later phase trials and industry-funded trials were more likely to report results. Another recent study found even lower compliance.

Still another paper looked at trials that were funded by the National Institutes of Health between 2005 and 2008, and found that only 46 percent were published in a peer reviewed biomedical journal indexed by Medline within 30 months of trial completion. And three years later, one third still remained unpublished.

In a widely quoted accompanying editorial, BMJ wrote that “there is an ‘Alice in Wonderland’ feel to these investigators’ efforts – acting on the public’s behalf, searching over hill and dale and among the paperwork of regulatory bodies and drug companies to put together pieces of data that should have been freely available in the first place” (here is the back story with links to the various papers).

Subscribe Now

Featured Partner